Entry to Regulatory

About the Role Remote Job, UK or Europe, Full-time or Part-time, competitive salary Deadline to Apply: 21st December You must be based in the UK or Europe & have the full right to work with no visa or sponsorship needs. About the Role We are a fast growing consultancy and training provider, and I am looking for a highly motivated Regulatory Affairs Manager to join our fast paced and exciting company. This is a unique opportunity for you to expand your skillset, take on more responsibility and excel in your career, as well as have the potential to manage a team. This is a pivotal, high priority role that combines hands on regulatory consulting with the unique opportunity to contribute to our professional training programs. I am looking for an experienced professional who can make a significant impact and contribution to the company based on their past success and experience through contributing to EU and UK regulatory submissions from clinical trials, through to marketing authorisation applications and variations. This may be you. Are you ready to take the next step in your career? I look forward to receiving your job application. You will be reporting directly to me, the CEO. About the Company: Hi, my name is Rabiea and I am the CEO of Advance Regulatory Consulting and Entry to Regulatory. Advance Regulatory Consulting is a regulatory affairs consultancy that provides consultancy services to the pharmaceutical and biotechnology industries to enable the successful development and commercialisation of medicines globally. In essence, we support the development of medicines and the regulatory approval process, so that lifesaving medicines can reach the patients who need them most. Entry to Regulatory is a regulatory affairs training company, where we train regulatory and aspiring regulatory affairs professionals in regulatory topics to support their careers and expand the profession. What we do is technical from a scientific perspective and provides a positive impact to patients and professionals across the globe. We provide: Expert Regulatory Affairs Consultancy: We partner with pharmaceutical, biotech, and academic clients, offering strategic and operational support across the entire product development lifecycle. Our specialisation lies in EU and UK regulatory affairs, with deep expertise in CMC, biologics, cell & gene therapies, and complex product development. Our team includes former health authority reviewers from the MHRA and EMA, ensuring unparalleled insight and a track record of successful "right-first-time" submissions. Professional Regulatory Affairs Training: Through Entry to Regulatory, we empower the next generation of regulatory professionals with comprehensive training programs, from entry level courses to advanced modules for senior leaders. We believe in sharing knowledge and fostering talent within the industry. Our commitment is to reduce time-to-market, minimise development costs, and ensure continued supply, always keeping our clients' needs and the patients who benefit at the heart of what we do. Why Apply? Our Work Environment Enables You To: Learn new skills Work from home Progress in your career Have a work life balance Excel in your personal development Change the ways of working - systems and processes Be part of a friendly and supportive work environment With honest and open working. We listen to your feedback Gain responsibility from the start to lead tasks and advise the CEO We have a genuine interest in your growth and development within the company Interview Process Deadline to Apply: 21ST December Application form ️ Test ️ HR Call ️ Technical Interview Target start date: January - February 2026 If you have any questions - see the email contact details in the application form. Here is What Our Staff Like About Us Akshaya - Marketing Assistant - 'Working in a fast paced environment, allowed me to grow in ways I couldn't have anticipated. The learning curve was steep but incredibly rewarding. The role gave me the freedom to explore different areas of marketing and communication. That kind of exposure is rare, and I'm grateful for the trust placed in me to lead and experiment. What stood out most was the culture of adaptability and learning. There was always space to try, fail, try again and eventually figure it out. That environment made all the difference in my personal and professional development.' Why Advance Regulatory Consulting / Entry to Regulatory? Joining our team means becoming part of a company that is truly making a difference. We offer: Meaningful Work: Contribute directly to accelerating innovation and ensuring patients have access to life changing medicines. Dynamic Environment: Thrive in a fast growing, entrepreneurial company where your contributions are highly valued and visible. Flexibility & Remote Work: Enjoy the benefits of a fully remote role with a focus on work life balance and autonomy. Expert Collaboration: Work alongside and learn from some of the most respected experts in the field, including former health authority regulators. Professional Growth: Significant opportunities for continuous learning, skill development, and career advancement, including building your profile as a trainer and thought leader. Supportive Culture: Be part of a collaborative, friendly, and supportive team that values open communication and mutual respect. Responsibilities Regulatory Strategy & Lifecycle Management Strategic Guidance: Develop and implement robust EU and UK regulatory strategies for pharmaceutical and biotechnology products, from early stage clinical development through to marketing authorisation and post approval maintenance. Full Lifecycle Support: Provide expert regulatory input for First-in-Human studies, clinical trial applications (CTAs/CTIS), Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug (IND) applications, Marketing Authorisation Applications (MAAs), and post authorisation activities (variations, renewals). Regulatory Intelligence: Advise clients on evolving regulatory requirements, guidelines, and best practices in the EU and UK, identifying potential risks and opportunities. Agency Interactions: Prepare for and participate in scientific advice meetings and other formal interactions with regulatory authorities (e.g., MHRA, EMA). Regulatory Submissions: Authoring & Review Dossier Development: Lead or significantly contribute to the authoring, review, and compilation of high quality regulatory dossiers and documents, ensuring compliance with relevant regulations and guidelines. Module 3 Expertise: Specialise in the preparation and review of Chemistry, Manufacturing, and Controls (CMC) sections (Module 3) for both clinical trial applications and marketing authorisation applications. Quality Assurance: Ensure all submissions are scientifically sound, well structured, and presented in a clear, concise manner to facilitate efficient agency review. Response Management: Coordinate and draft responses to regulatory agency questions and deficiency letters, working collaboratively with client teams. CMC Regulatory Leadership Technical Translation: Translate complex manufacturing and quality data into clear, compliant regulatory submissions. Change Management: Provide regulatory oversight and support for manufacturing process changes, analytical method development, technology transfers, and site changes. Strategic Input: Offer strategic CMC input throughout product development to ensure regulatory compliance and optimise development timelines. Training & Professional Development Content Development: Collaborate with our training team to design, update, and enhance engaging training materials for our diverse range of regulatory affairs courses (e.g., Introduction to Regulatory Affairs, Excel, Expand programs). Delivery & Presentation: Deliver compelling presentations and lead interactive sessions for both our public courses and bespoke in house client training programs. Mentorship: Potentially mentor junior professionals or course participants, sharing your expertise and fostering their growth in regulatory affairs. Thought Leadership: Contribute to our knowledge base through articles, webinars, or other content that highlights our expertise and thought leadership (optional, based on interest). Client Consulting & Relationship Management Trusted Advisor: Serve as a primary regulatory contact for assigned clients, building strong, long term partnerships based on trust and expertise. Problem Solving: Provide pragmatic, solution oriented regulatory advice that addresses client challenges while maintaining compliance. Project Management: Manage regulatory projects effectively, ensuring timely delivery of high quality work within agreed upon scopes. Internal Contribution & Company Growth Process Improvement Actively contribute to the continuous improvement of our internal processes, templates, and best practices. Strategic Input: Provide valuable insights and feedback to help shape the development of new consulting services and training offerings. Team Collaboration: Work closely with a supportive and collaborative team, contributing to our vibrant company culture. Requirements . click apply for full job details

A dynamic consultancy based in the UK is seeking a motivated Regulatory Affairs Manager. This pivotal role includes developing regulatory strategies and managing submissions for pharmaceutical products. Candidates must have a minimum of 5 years of experience in regulatory affairs, with strong skills in project management and communication. The position offers remote work flexibility and opportunities for professional growth within a supportive team environment.