293 jobs found

We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team. This role offers the flexibility of being home or office-based in various European countries. About the Role: As a Regulatory Affairs Project Manager, you will be at the forefront of leading internal projects for Parexel clients. You will provide a broad range of consulting services, working within project guidelines to identify, refine, and address client issues while achieving project objectives. Key Responsibilities: Own client relationships and ensure high client satisfaction through effective communication Lead project initiation, execution, control, and closure processes Manage projects to completion within budget, schedule, and contract specifications Oversee resource planning, team management, and budget control Ensure compliance with quality standards, SOPs, and local regulations Provide guidance to project team members on technical and process issues Qualifications: University Degree in a Scientific or Technical Discipline (Advanced Degree preferred) Extensive experience in Regulatory Affairs within an industry-related environment Strong project management skills (PMP or equivalent certification is a plus) CRO experience Excellent financial management skills Outstanding interpersonal and intercultural communication skills, both written and verbal Fluency in English

Head of Government Affairs UK page is loaded Head of Government Affairs UK Apply remote type Hybrid locations London - The Shard time type Full time posted on Posted 6 Days Ago job requisition id R-93289 Job Description We have an excellent opportunity available for an experienced Head of Government Affairs to make a difference at Kraft Heinz. You will shape the external policy environment to support our commercial goals, drive sustainable business practices, and foster our reputation as a responsible food manufacturer. You will be responsible for building a new government affairs (GA) ecosystem to position Kraft Heinz as a thought and knowledge partner with government. Working closely with the Managing Director for the UK & Ireland, you will ensure that the organisation has a strong voice in public policy discussions and contributes to shaping legislation or regulatory frameworks relevant to our business. This is a meaningful role at the intersection of policy, business, and brand. This role lies within the European Developed Markets business unit. The position is based in London, located in the Shard, and will report to the Director for Government Affairs Europe, based in Brussels. Owning the development and execution of Kraft Heinz's GA and public affairs strategy in the UK will be your primary responsibility. You'll be working in a high performing team, alongside peers always trying to reach the next level! What you'll do Develop a long-term UK GA strategy and serve as an outstanding strategist and tactician in terms of planning and delivery. Guide the UKI Managing Director in engagement with senior political and industry leaders. Advise senior leadership and commercial teams on potential risks and opportunities arising from the policy landscape. With our agency partner, supervise and assess policy and regulatory developments affecting the food sector, including nutrition policy, packaging and sustainability, economic policy and trade. Build and maintain relationships with key collaborators across Westminster, devolved governments, local authorities, regulatory and institutional bodies (e.g., DEFRA, DBT), and relevant industry associations (e.g. IGD). Develop and deliver briefings, position papers, consultation responses, and public submissions on key legislative or regulatory proposals. Lead external messaging on policy, corporate announcements, and key business initiatives. Represent Kraft Heinz at external meetings, roundtables, parliamentary receptions, and industry forums. Support engagement with NGOs, think tanks, and advocacy groups on shared policy objectives (e.g., food reformulation, carbon reduction). Collaborate closely with internal teams across Legal, Regulatory, Sustainability, Procurement, R&D, and Communications to ensure alignment on public affairs activity. Mentor and leverage internal experts in government engagement. What you'll need: Guideline minimum of 10-years' experience in a public affairs, government relations, or policy role, ideally within a large FMCG or highly regulated sector. A strong understanding of the UK political and policy-making landscape coupled with a strong network. Specific knowledge of food, health, and sustainability policy is a plus. Self-starter with the ability to work independently and proactively in a fast-paced environment that requires management of multiple projects simultaneously. Familiarity with devolved government policy environments and experience with international and UK-EU trade challenges. Excellent written and verbal communication skills with the ability to engage and influence at all levels. Desired skills & attitude: Ability to speak fluently in lay terms to a range of audiences about the business and priorities and challenges of Kraft Heinz. Capability to make nuanced recommendations and business decisions based on facts and the work environment of Kraft Heinz. Comfortable with ambiguity, both internally and externally, using strong communication and problem-solving skills. Public affairs campaign skills, including involving traditional and social media. A relevant degree or equivalent experience (e.g., Politics, Public Policy, Law, Communications, or Food Science). What we offer you We are an ambitious employer with an industry-recognised career development pathway We have a meritocratic, pay for performance approach Flexible and hybrid working approach, including ability to work from abroad Inclusive culture/work environment, backed by leadership-sponsored Business Resource Groups Family-friendly; market leading parental leave benefits & sponsored nursery scheme Wellbeing Private medical cover & Digital GP Best-in-class gym discounts & cycle to work scheme Premium membership to Calm App 3 volunteering days per year (e.g. Soup Kitchen, Magic Breakfast) Location(s) London - The Shard Kraft Heinz is an Equal Opportunity Employer - Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity and other protected classes. ABOUT US Kraft Heinz is a global food company with a delicious heritage.With iconic and emerging food and beverage brands around the world, we deliver the best taste, fun and quality to every meal table we touch. We're on a mission to disrupt not only our own business, but the global food industry. A consumer obsession and unexpected partnerships fuel our progress as we drive innovation across every part of our company. Around the world, our people are connected by a culture of ownership, agility and endless curiosity. We also believe in being good humans, who are working to improve our company, communities, and planet.We're proud of where we've been - and even more thrilled about where we're headed - as we nourish the world and lead the future of food. WHY US We grow our people to grow our business. We champion great people who bring ambition, curiosity, and high performance to the table as the guardians of our beloved and nostalgic brands. Good isn't good enough.We choose greatness every day by challenging the ordinary and making bold decisions. All while celebrating our wins - and our failures - as we work together to lead the future of food. Challenging the status quo takes talent.We invest in your purpose and potential by developing skills and nurturing strengths that leave a legacy on our business and a lasting impact on your career. Because great people make great companies, and we're growing something great here at Kraft Heinz. INCLUSION MATTERS TO US Everyone is welcome at our table. In fact, we thrive on learning and growing from our diverse backgrounds and perspectives. Doesn't matter who you are, where you're from, or who makes your heart sing. We want you to show up as your authentic self, excited to work with amazing colleagues to solve complex challenges and innovate in an ever-changing industry. We're committed to: Hiring and growing talent from diverse backgrounds and perspectives. Growing our Business Resource Groups - vibrant, celebrated communities that enhance our business through thought leadership employee engagement and professional development opportunities. Providing our managers and leaders high quality learning experiences to explore how to foster inclusion and belonging.

Regulatory Affairs Knowledge Management Capability Lead Job ID REQ- May 30, 2025 United Kingdom Summary Job Description Summary As a member of the Knowledge & Content Management Platform team, the Knowledge Management Capability Lead contributes to the strategic vision of Regulatory Affairs and supports the digitalization and centralization of Knowledge Management in Regulatory Affairs, by overseeing one or several product(s) underlying the Capability. The Knowledge Management Capability is supporting knowledge gathering and sharing across the organization, as well as the leveraging of collaboration tools. This capability is defining the strategy for successful deployment and usage of knowledge management technologies, best practices, and advising on information structure. The capability is also supporting regulatory requirements gathering and availability, as well as advocating for an harmonized approach through the leveraging of state-of-the-art enterprise tools. The Capability should also ensure high user adoption & scale-up, and easy retrieval of information potentially leveraging Artificial Intelligence. The Knowledge Management Capability Lead is accountable to ensure that the Capability strategy delivers business benefits, and to drive harmonization and continuous improvements. About the Role Key Responsibilities Responsible to ensure alignment of a team with organizational goals and business priorities related to Knowledge Management Support the strategic vision for the Knowledge & Content Management Platform, from a Capability level Act as a Change Lead to drive system adoption, communication and training, at the capability level: implement change management strategies to ensure smooth adoption of technology initiatives Define, prioritize, and deploy an integrated capability roadmap working in close collaboration with relevant stakeholders and DDIT partners, ensuring alignment with the Knowledge & Content Management Platform, Development and Enterprise technology strategy roadmaps Represent the Capability in digital governance boards and leadership meetings across the organization and in digital networks, externally (e.g. across Industries) as needed Communicate effectively to ensure understanding and support for new technology initiatives Support continuous expansion of knowledge and foster the adoption of a digital mindset within the Regulatory Affairs team Oversee vendors at the capability level, across product(s), in collaboration with IT and the External Partnerships Teams Oversee integrations with products underlying the Capability. Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned capability/product(s), aligned with the NVS Quality Manual Contribute to the change management strategy to ensure smooth adoption of technology initiatives, as required Ensure adherence to Security and Compliance policies and procedures within the scope of the Capability, and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections). Responsible for Product(s) within the Capability. Can act as a product manager and a product owner Ensure on time, compliant, secure, and quality delivery of portfolio for the assigned product(s), partnering with relevant IT functions. Responsible to approve product-related requirements across product(s) underlying the Capability Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders Provide support/resources for key projects and programs with impact to the underlying product(s), ensuring timely delivery of high-quality milestones in alignment with business requirements. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? : Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Travel booking administrator page is loaded Travel booking administrator Apply locations London, United Kingdom time type Full time posted on Posted 3 Days Ago job requisition id R Job Overview Under guidance, assist with the identification of opportunities from vendor expenditure, and work with colleagues to realize benefits for a variety of purchasing category initiatives. Ensure adherence to the IQVIA Transnational corporate purchasing policy which encourages vendor competition. Essential Functions: Conducts the travel booking requirements for internal and external meetings and events. Conducts the financial and accounting operations of the organization. Prepares, collects and interprets financial information; prepares budgets, reports, forecasts and statutory returns; conducts financial analyses of proposals, investments and fund sources; manages the organization's taxation affairs; manages cost accounting systems and cash flow; conducts audits; controls treasury and ensures compliance with regulatory standards. Coordinate activities within the team and identifies outstanding tasks. Engage with internal and external customers. Marketing and presentation of team's service offering. Coordinate flight travel arrangements for IQVIA and Non-IQVIA employees, including some limited, accommodation, transportation, and itineraries. Perform other duties as assigned. Qualifications High School Diploma or equivalent Req Or Bachelor's Degree Req 5 years' experience Req Or Equivalent combination of education, training and experience. Req Knowledge of sourcing methodologies, processes and practices. Knowledge of supply chain management, materials management, purchasing or procurement. Knowledge of Microsoft Office applications. Technical accounting skills. Data analysis and manipulation skills. Ability to exercise judgment within procedures and practices to determine appropriate action. Ability to prioritize and coordinate multiple work requirements to meet deadlines. Ability to establish and maintain effective working relationships with co-workers, managers and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at About Us IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

Who We Are Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. What You'll Do We are hiring a full time (Homebased/Remote) Senior Regulatory Affairs Manager either based in the UK, France, Italy, Spain, Sweden or Republic of Ireland. The primary responsibilities of this position include, but are not limited to, the following: Provides regulatory (strategic, tactical, operational) input to all projects managed by Regulatory Affairs Europe, as needed. Manages preparation, assembly and submissions in EU/EEA and UK of: Clinical Trial Applications (CTAs), amendments/modifications and notifications Country-level Informed Consent Forms and other patient facing documentation Other regulatory documents required for submission purpose only e.g., GDPR statement, Recruitment Procedure Participates in the quality control (QC) steps involved for all the above. Tracks, reports and files CTA and amendment/modification submissions/approvals in local regulatory repository, electronic Trial Master Files (eTMF) and other applicable systems. Prepares presentations for Kick Off Meetings (KOM) with clients and represent Regulatory Affairs at such meetings. Identifies and proactively communicates regulatory issues and risks including risks related to country specific requirements and provides associated mitigation as required to ensure applications and notifications are submitted within agreed timelines. Identifies country specific requirements as well as the need for additional country specific applications besides CTIS/IRAS applications e.g., related to radiation safety and biobanks Serves as key regulatory liaison for multi-continental projects on behalf of Theradex Oncology (Europe). Liaison with other departments within Theradex, including but not limited to Clinical Operations Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution. Act as Subject Matter Expert for specific assigned topics e.g., Medical Device, National requirements related to C-ICF in a group of countries Responsible for assigned Regulatory SOPs and other Quality Documents and ensure they are updated/reviewed within set timelines. Proactively identify the need for ad-hoc updates of Regulatory Quality Documents Review scientific documents such as IMPDs, DSURs, study protocols and IBs and provide input from a regulatory perspective when requested Validate and provide input into our clients' regulatory development strategies, support our clients in preparing for Scientific Advice meetings with EU Competent Authorities and the EMA and prepare applications such as Orphan Drug, Compassionate Use where required Keep up to date and interpret guidelines and regulations for preparation of CTAs and in response to sponsor questions. Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by ECs and CAs. Supports the Head of Regulatory Affairs in business development activities including the preparation of client proposals and bid defense meetings. Provides regulatory training to other members of the team as required. What You Need Level of Education: Bachelor's degree required preferably in a life science field or equivalent. Prior Experience At least 5 years of experience from the pharmaceutical industry industry or CRO in a regulatory role within the area clinical trials required Prior experience in a CRO environment preferred Direct experience of CTIS and IRAS CTA preparations and submissions is required Experience from national applications such as GMO, radiation safety is preferred Skills and Competencie Completion of Theradex Oncology training programme Detailed knowledge of ICH-GCP and EU and UK regulatory agency and ethics committee regulations and requirements The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities Demonstrates ability to build and maintain effective relationships with others, establishing collaborative partnerships, trust and shared purpose Excellent interpersonal skills Strong management skills and the proven ability to meet deadlines Ability to anticipate problems relating to projects and to develop and implement solutions. Excellent interpersonal skills Fluent knowledge of written and verbal English Highly organized and result-oriented Ability to work independently as well as in a team environment Proficient knowledge of Microsoft Office packages including but not limited to Word and Excel This job does not offer company sponsorship Theradexis an equal opportunity employer. All qualified applicants are encouragedto apply and will receive consideration for employment.

Regulatory Affairs Consultant - Cosmetics Brussels, BE Do you want to contribute to a safe European market while gaining an authentic international experience as a consultant? Obelis is currently looking for a Regulatory Affairs Consultant - Cosmetics to join our Regulatory Affairs Department. Your role and key responsibilities will be: 1. Provide professional and smooth external/internal client service at the highest level 2. Perform tasks associated with the Regulatory Affairs department at the highest level Provide service covering all product Regulations (EU UK and US), with Focus on Cosmetics Regulations Process EU/UK/US applications (Notifications, registrations, GMDN, FSC) Respond to queries related to file submissions from EU authorities Process documentation review 3. Follow-up on tasks assigned 4. Contribute to relevant business research on requirements 5. Contribute to online and offline publications 6. Provide ah-hoc assistance to the DPM/Department Manager 7. Provide internal trainings on department related matters 8. Support the implementation of ISO 9. Represent Obelis and its interest at external events Requirements Bachelor/Master degree in European Law, Pharmacy, Biotechnology, Quality Management Systems or similar At least 3 years professional experience in chemical/cosmetic sector Knowledge of GMP, ISO 9001 and ISO 13485 requirements Experience in EU applications and administration procedures Fluency in English (written & oral) Proficiency at Microsoft word, Excel, PowerPoint, Outlook. Be able to and willing to travel in / out of the European Union. We believe that each of our employees has the potential to make a significant contribution. As a result, we take great care when it comes to the satisfaction of our employees. Here is what you can expect: Fulfillment - access to the best available technologies and experts Traveling - opportunities to participate to international events (Exhibitions, missions and seminars) Work/Life Balance - Flexi-time Special Benefits - Mobile subscription, Health Coverage, Teleworking From Abroad Days, Extra Paid Days Off, Meal Vouchers, professional courses, etc. Employee Satisfaction before client Satisfaction" is the driving force of Obelis as an organization About Obelis Group Obelis Group is a quality driven, service-oriented company with over 30 years of experience in regulatory affairs. Obelis was founded by Gideon Elkayam back in 1988 vision to create a bridge between non-European manufacturers and the European market by "creating compliance for safer markets" . Over the years, the organization has helped over 3,000 manufacturers from more than 70 countries in their compliance journey. Today, Obelis is the largest center in Europe for CE marking & EU Representative Services, and a proud member of EAAR (The European Association of Authorized Representative) & ERPA (European Cosmetics Responsible Person Association) & EU Commission Working Groups. Ready to join us? Submit your CV & motivation letter in English to By submitting your application you accept Obelis Privacy Policy. Our Recruitment Team will contact you via email if your profile is suitable for this position. Early application is recommended. Every CV will be carefully reviewed, however due to volume of applications only successful candidates will be contacted.

Regulatory Affairs & Stewardship Specialist Anglo American is a leading global mining company, and our products are the essential ingredients in almost every aspect of modern life. Our portfolio of world-class competitive mining operations and undeveloped resources provides the metals and minerals that enable a cleaner, greener, more sustainable world and that meet the fast-growing consumer-driven demands of the world's developed and maturing economies. We are constructing a state-of-the-art underground mine to enable the extraction of Polyhalite - a unique multi-nutrient fertiliser - along with the necessary infrastructure both above and below ground that will be required for transport, processing, and distribution. POLY4 is our flagship multi-nutrient fertiliser product. Made from polyhalite, it contains four of the six macro-nutrients and many micronutrients that are essential to plant growth. It allows farmers to maximizetheir crop yield, increase quality and improve soil structure with one simple product. Job Description : Join us as a Specialist: Regulatory Affairs & Stewardship , where you will play a pivotal role in managing the regulatory and registration portfolio of our Crop Nutrients business - ensuring maximum freedom to operate across multiple jurisdictions. You'll provide technical support across Product Stewardship, Logistics, Regulatory, and Quality Management, helping to uphold our high standards and compliance globally. Your responsibilities will include: Product Stewardship : Support the Commercial team in establishing and continuously improving a Product Stewardship Program. Logistics & Quality Support : Assist the Logistics and Quality teams in organizing inspections by external surveying companies and maintaining all quality-related documentation for shipments and deliveries. Regulatory Support : Collaborate with the Regulatory Manager to support global product registration processes for POLY4 and related products. Data & Document Management : Maintain the regulatory database and SharePoint documentation to ensure accuracy and accessibility. Compliance Assurance : Ensure all required regulatory product documentation (e.g. technical files, certificates, product labels & Safety Data Sheets) arein place to meet global compliance standards. New Product Development : Ensure new product developments are compliant with legal and best practice requirements through proper documentation. Label Management : Create and maintain product labels in accordance with regulatory standards. SDS Review : Review and update Safety Data Sheets to ensure accuracy and compliance. Regulatory Reporting : Work with the Commercial team to complete U.S. tonnage, CBAM and tax reporting requirements. Legislation Monitoring : Monitor new legislative and regulatory changes, and communicate relevant updates to internal stakeholders. Qualifications : BSc or MSc in a scientific discipline (e.g. Chemistry, Environmental Science, Agronomy, or related fields) Experience working with regulatory authorities or within a regulatory environment Strong communication skills and attention to detail Awareness of the commercial impact of regulatory and quality decisions Technical Knowledge Solid understanding of regulatory processes in areas such as Fertilisers, Chemicals (REACH), and/or Plant Protection Products Familiarity with Classification, Labelling and Packaging (CLP/GHS) regulations and Safety Data Sheets (SDS) Ability to interpret and apply local and regional legislation, company protocols, and industry standards Basic understanding of logistics and supply chain operations Knowledge of developing and maintaining Quality Assurance systems Ability to interpret scientific data and regulatory documentation Chemical knowledge and understanding of manufacturing processes and quality management principles are advantageous Location: This role can be based in eitherLondonor Woodsmith Mine,Whitby Additional information : Who we are :We aim to lead the industry by pursuing ever safer and more responsible ways of working, demonstrating integrity and showing care and respect for people and the planet. That means we are constantly seeking new opportunities to mine and process our products sustainably, using less water, less energy and more precise extraction technologies. As the custodians of coal and other precious natural resources - diamonds (through De Beers), copper, platinum and other precious metals, iron ore and nickel - our extraordinary teams work safely and collaboratively, with the utmost consideration for local communities, our customers and the world at large. What we Offer: When you join Anglo American, you can expect to enjoy a competitive salary and benefits package. But more than this, you'll find yourself in an environment where the opportunities for learning and growth are second to none. From technical training to leadership programs, we bring out the best in our people. There are plenty of opportunities to move onwards and upwards too. We're a large, successful multinational company - and we're still growing all the time. How we are committed to your safety: Nothing is more important to us than ensuring you return home safely after a day's work. To make that happen, we have the most rigorous safety standards in the industry. Not only that, we're also continually investing in new technologies - from drones to data analytics - that are helping to make mining safer. Inclusion and Diversity: Anglo American is an equal opportunities employer. We are committed to promoting an inclusive and diverse workplace where we value and respect every colleague for who they are and provide equality of opportunity so that everyone can fulfil their potential.

East Coast, United States; New York, United States Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways . Job Overview: The Senior Manager, Regulatory Affairs will be a strategic thinker, responsible for researching and assessing regulatory precedence and contributing to regulatory strategies for development of Compass Pathways investigational drug programs. As assigned, this individual will be responsible for application maintenance activities, amendments, supplements, regulatory intelligence activities, and other policies and procedures. This position assists in maintaining organization's Regulatory Affairs operational functions and direct lines of communication for, interactions with, and access to Regulatory Authorities/Agencies in the US and abroad, in compliance with regulatory guidance, regulation and laws. This position is a generalist role and will be part of a regulatory team. The individual will have collaborative and leadership skills to allow for successful cross functional interactions with the organization. Location : Remote on the East Coast in the United States or hybrid in our New York City office. Reports to : Senior Director, Regulatory Affairs Roles and Responsibilities: (includes but are not limited to) Supports the execution of regulatory strategies and implementation plans for the preparation and submission of investigational and new drug applications, amendments, investigator filings, annual reports, and associated labelling Manages assigned regulatory communications and assists with preparation activities for Agency meetings, responses to Agency requests, and pre-meeting packages to ensure the organization complies with applicable regulation and guidance Manages regulatory intelligence process - monitors for new or changing regulations and coordinates internal stakeholders to ensure development of strategies to address applicable changes Supports management of regulatory applications to ensure compliance with regulations, including tracking of submission timelines, coordination of authoring and review of submission deliverables, and proactive identification and communication of delays and risks Acts as a regulatory representative on assigned project teams, providing regulatory guidance and recommendations in line with company goals, applicable laws and regulations, and the overall regulatory strategy Liaises with the Regulatory Operations team to coordinate publishing activities and timelines for assigned submissions Conducts regulatory research in relation to assigned programs and disseminates relevant information to management and cross-functional teams Performs other regulatory responsibilities/duties as assigned by the Senior Director, Regulatory Affairs Candidate Profile: Considerable regulatory experience in a CRO/biotech/pharmaceutical company BSc degree in relevant/related discipline/industry required, advanced degree a plus Experience in CNS/psychiatric therapeutic area a plus Extensive experience with Microsoft Word and PowerPoint, Adobe Acrobat; familiarity with SharePoint, ISI Writer and/or similar common pharma/biotech industry applicable platforms; Microsoft Project experience a plus Experience in interpretation of regulations, guidelines, policy statements, etc Experience and knowledge in the preparation of regulatory submissions, including amendments or supplements Strong attention to detail and the ability to manage multiple tasks Collaborative attitude and willingness to work in a cross-cultural environment Ability to work in a fast pace and dynamic atmosphere Adaptive thinking and "can-do" spirit Strong team player and communicator - proactive planner and solutions oriented Ability to work both independently with minimal supervision and within a matrix management structure Experience working with third party vendors, consultants and external partners Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. Base salary per annum : $166,000 - $215,000 USD Benefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass ". Equal opportunities: UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship : Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data. Create a Job Alert Interested in building your career at Compass Pathways? Get future opportunities sent straight to your email. 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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Regulatory Affairs Manager Swindon, UK/Full time Work Schedule Standard (Mon-Fri) Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies! Perform regulatory surveillance Assess regulatory feasibility of any new request (primary focal point) and address local impact. Establish centre of expertise to be shared within Thermo Fisher network. Externally, participate to working groups within professional bodies. Supervise the maintenance of all official authorisations (MIA human and veterinary & MIA IMP - MS - ISO - GMP certificate) and establishment master documentations (SMF - DMF - device technical file) collaborating with appropriate regulatory agencies. Ensure inspections & key audits readiness and/or participate. Responsible for archiving official documents. Supervise the maintenance of regulatory data bases (Client product registration information, components). Ensure integration of registration information into Production and Quality master documents (process and QC specifications). Participate to the Change Control process by defining regulatory requirements. Acknowledge regulatory quotations and follow-up on invoices for reporting of financial indicators. Identify areas of regulatory business opportunities (PDS and others). Provide regulatory guidance (strategy definition, requirements assessment). Coordinate the authoring of CMC/Quality documentations (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) and review. Supervise Client registration life-cycle activities (renewals, MoH questions). Requirements: To be successful in this role, you must possess experience in regulatory affairs, particularly within the legal framework. You should have: B.Sc. or equivalent experience in Pharmacy, Chemistry, or Microbiology, or related science A minimum of 7 years hands-on theoretical and practical regulatory affairs (including filling activities) as well as site regulatory compliance activities. UK, European, US & International main pharmaceutical regulations (including GMPs). Knowledge of the workings of UK Ministry of Health. Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements Dynamic, self-motivated, pro-active approach to taking on challenging assignments. Strong communication and collaboration skills Ability to work with critical timelines. Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans. We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries.

Job Description Summary (3 days per week on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Manager We are seeking an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is essential in shaping regulatory strategy and overseeing operational activities across key regions. You will work with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory standards, supporting the development and commercialization of pharmaceutical products. Major Responsibilities: Implement regional regulatory strategies aligned with global objectives. Contribute to global regulatory planning, identifying strategic gaps or risks. Lead or support interactions with Health Authorities (HAs), including preparing briefing materials. Coordinate timely and compliant regulatory submissions across assigned regions. Review and approve Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans. Act as liaison with local HAs (e.g., FDA, EMA) as required. Ensure timely and effective responses to HA queries and requests. Collaborate cross-functionally to align regulatory plans with business goals. Monitor and ensure compliance with internal policies and external regulations. Support or lead negotiations for regional approvals to meet project timelines. Essential Requirements: Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Proven experience in regulatory affairs within the pharmaceutical industry. Strong understanding of drug development and clinical trial processes. Experience managing regulatory submissions and HA interactions. Commitment to Diversity and Inclusion/EEO Novartis is dedicated to building an inclusive and diverse work environment that reflects the communities we serve. Why Novartis: Helping people with disease and their families requires more than science. It takes a community of passionate, innovative individuals like you. Join us in creating breakthroughs that change lives. Learn more about our culture Join our Novartis Network: Stay connected and learn about future opportunities by signing up to our talent community: Benefits and Rewards: Discover how we support your growth at Skills Desired

Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations. As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly. Key Responsibilities of Regulatory Affairs Manager : Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks. Prepare, submit, and maintain product registration dossiers and regulatory filings. To complete the REACH registration of the full product range within the time limits set by ECHA. Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product. Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold. Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes. Represent the company with regulatory agencies and industry associations. Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts Qualifications required from Regulatory Affairs Manager : Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field. Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing. Working knowledge of international chemical regulations and compliance systems. Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation. What We Value: We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace. This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you. Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.

Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Sr. Manager, EMEA Nuclear Regulatory Affairs Requisition Number: 26232 Company: W Electric Company UK Ltd Location: Salwick Preston, GB Senior Manager, EMEA Nuclear Regulatory Affairs Westinghouse Electric Company Springfields Welcome to the future of nuclear energy , where Westinghouse Electric Company is leading the field with expertise and innovation to shape the power of tomorrow. At Westinghouse, innovation is in our DNA. We are creative. We think differently. We reimagine the possible across the nuclear industry every day. About the role: As a Sr. Manager you will direct and lead the nuclear regulatory affairs activities in support of Westinghouse business objectives in EMEA. These include the coordination and integration of activities, within and between Global Nuclear Regulatory Affairs, the EMEA Business Unit, and GOS facilities in EMEA with nuclear licenses issued by their national regulators. You will report to the Vice President, Global Nuclear Regulatory Affairs and be located at Springfields. This is a remote position, and you can expect occasional business travel, mainly within Europe. Key Responsibilities: Provide Regulatory Support, Guidance and Oversight for Westinghouse Businesses, Products and Services: Cultivate and maintain strong working relationships with the key EMEA nuclear regulators directly or by working with GOS facilities to ensure they take appropriate steps to maintain such relationships. Support the business unit by helping navigate any regulatory hurdles to acquiring new business. Apply regulatory knowledge to identify, integrate, and where appropriate direct acceptable resolution of technical and regulatory issues addressing customer or Westinghouse requirements. Provide for Westinghouse response and engagement to international regulatory bodies; industry and standards organizations based on alignment with the business unit and global regulatory affairs needs and expectations. Ensure all EMEA locations have a strong inspection preparation and follow up program. Serve as the primary Westinghouse interface with nuclear regulatory agencies in EMEA; Maintain awareness of significant regulatory interactions when the Westinghouse licensed facility is the primary contact. Ensure implementation of Global Regulatory Affairs initiatives within EMEA. Develop and implement strategies to ensure Westinghouse has a strong relationship with the key regulators. Resolve EMEA business unit and GOS regulatory issues either directly or by supporting the licensed facilities as needed. Coordinate regulatory activities on behalf of GNRA with GOS facility, EH&S and Legal organizations. Implement global regulatory affairs initiatives. Identify, prioritize and represent Westinghouse on selected international and industry organizations. Lead nuclear regulatory activities to ensure projects, initiatives and processes are in conformance with established policies and objectives. With support from GNRA, ensure EMEA is appropriately implementing the Westinghouse Part 21 program. Engage the business unit in the proposal phase for any significant new projects and/or due diligence phase for mergers/acquisitions to ensure nuclear regulatory requirements have been appropriately considered. Includes managerial responsibilities related to leading regulatory affairs activities and coordinating cross-functional teams across the EMEA region Maintain cognizance of the certification status of packages Westinghouse uses to ship Radioactive Material (RAM), including new fuel, throughout EMEA. Assist the transportation group as needed to ensure packages remain certified (or re-certified) to support our business needs. Qualifications: 10+ years experience required, with detailed knowledge of at least one key EMEA nuclear regulatory. Proven experience dealing with nuclear regulators is an essential characteristic. Established relationships with key regulatory leaders. Bachelor's degree in technical or business area is typically required. MBA or Master's degree is highly. Broad business acumen punctuated by incorporation nuclear regulatory requirements in decision making. Demonstrated ability to work within the organization and with Customers at all levels creating value and alignment. Superior ability to communicate clearly in writing, verbally and through presentations. Strong relationship building characteristics balanced with tenacity and challenging attitude. Why Westinghouse? We know that to put forth your best effort, you need to be challenged and enjoy what you do in a supportive and respectful environment. We aim to maintain this balance by offering our employees the amenities, benefits and training they need to reach personal and professional goals. Below is an example of what employees in the UK can expect: Attractive remuneration Great benefits for your convenience and safety: Peer-to-peer recognition program. Life insurance Pension plan Employee Assistance Program: confidential counseling and resources for employees, eligible dependents, and household members Learning and development opportunities. We encourage our employees to participate incommunity service eventsand other team-building activities to strengthen their bonds and inspire each other. Westinghouse is an Equal Opportunity Employer including Veterans and Individuals with Disabilities. Employment opportunities may require access to information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States. Job Segment: Regulatory Affairs, Nuclear, Compliance, Law, MBA, Legal, Energy, Management

Global Regulatory Affairs Manager (Global Program Regulatory Manager) Job ID REQ- United Kingdom Summary (3 days per week on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Manager We are looking for an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is critical in driving regulatory strategy and managing operational activities across key regions. You will collaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and commercialization of pharmaceutical products. About the Role Major Responsibilities: Implement regional regulatory strategies in alignment with global objectives. Contribute to global regulatory planning and identify strategic gaps or risks. Lead or support Health Authority (HA) interactions, including briefing material preparation. Coordinate timely and compliant regulatory submissions across assigned regions. Review and approve Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans. Act as a liaison with local HAs (e.g. FDA, EMA) as required. Ensure timely and effective responses to HA queries and requests. Collaborate cross-functionally to align regulatory plans with business goals. Monitor and ensure compliance with internal policies and external regulations. Support or lead negotiations for regional approvals to meet project timelines. Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Proven experience in regulatory affairs within the pharmaceutical industry. Strong understanding of drug development and clinical trial processes. Experience in managing regulatory submissions and HA interactions. Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Alternative Location 1 Dublin (NOCC), Ireland Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.