Title: Regulatory Project Management Consultant Location: Munich, Germany Relocation: Supported - visa sponsorship available (Blue Card) The Company This is one of Europe's most respected regulatory consulting firms, known for delivering high-level strategic advice across drug and device development. Privately owned and organically grown over the past 20 years, they've supported over 1,000 clients worldwide with complex regulatory challenges. This is not an outsourced CRO model - they focus on quality-driven consulting underpinned by deep scientific expertise. Their team is tight-knit, highly technical, and collaborative, with a 98% consultant retention rate and a strong reputation for excellence. Based in Munich, the company offers hybrid working and a culture that prioritises autonomy, integrity, and hands-on problem-solving. The Role This is a hands-on regulatory project management role focused on global submissions. You will lead planning and coordination from early-stage scientific advice through to full MAA, BLA, or NDA submissions. The role is client-facing and involves managing timelines, coordinating internal resources, and overseeing documentation across Modules 1-5. It's ideal for someone who enjoys structure, precision, and owning delivery from end to end. Responsibilities Lead full lifecycle management of EU and US regulatory projects Oversee submission content across Modules 1-5 Manage project timelines, resources, and documentation workflows Act as the main point of contact with regulatory authorities and clients Coordinate and support scientific advice meetings Ensure regulatory compliance, quality, and on-time delivery Candidate Profile Master's or PhD in life sciences, medicine, or a related field At least 10 years of experience in regulatory affairs and project management Strong knowledge of FDA, ICH, and EU regulatory guidelines Demonstrated experience with agency interactions and lifecycle management Skilled with project planning tools (e.g., MS Project, Smartsheet) Fluent in English with clear communication skills Highly organised, detail-focused, and comfortable managing multiple complex submissions
Jul 27, 2025
Full time
Title: Regulatory Project Management Consultant Location: Munich, Germany Relocation: Supported - visa sponsorship available (Blue Card) The Company This is one of Europe's most respected regulatory consulting firms, known for delivering high-level strategic advice across drug and device development. Privately owned and organically grown over the past 20 years, they've supported over 1,000 clients worldwide with complex regulatory challenges. This is not an outsourced CRO model - they focus on quality-driven consulting underpinned by deep scientific expertise. Their team is tight-knit, highly technical, and collaborative, with a 98% consultant retention rate and a strong reputation for excellence. Based in Munich, the company offers hybrid working and a culture that prioritises autonomy, integrity, and hands-on problem-solving. The Role This is a hands-on regulatory project management role focused on global submissions. You will lead planning and coordination from early-stage scientific advice through to full MAA, BLA, or NDA submissions. The role is client-facing and involves managing timelines, coordinating internal resources, and overseeing documentation across Modules 1-5. It's ideal for someone who enjoys structure, precision, and owning delivery from end to end. Responsibilities Lead full lifecycle management of EU and US regulatory projects Oversee submission content across Modules 1-5 Manage project timelines, resources, and documentation workflows Act as the main point of contact with regulatory authorities and clients Coordinate and support scientific advice meetings Ensure regulatory compliance, quality, and on-time delivery Candidate Profile Master's or PhD in life sciences, medicine, or a related field At least 10 years of experience in regulatory affairs and project management Strong knowledge of FDA, ICH, and EU regulatory guidelines Demonstrated experience with agency interactions and lifecycle management Skilled with project planning tools (e.g., MS Project, Smartsheet) Fluent in English with clear communication skills Highly organised, detail-focused, and comfortable managing multiple complex submissions
Sales Director - Life Sciences SaaS (Remote, UK) A rapidly scaling, innovation-driven SaaS provider within the life sciences sector is looking to appoint a Sales Director to drive new business growth across pharma, biotech, and CRO markets. The company offers cutting-edge solutions that enhance clinical trialregulatory compliance. This is a remote-first role open to UK-based candidates, with occasional international travel. Key Responsibilities: New Business Development : Identify, qualify, and close new business opportunities within pharma, biotech, and CRO sectors Map and engage key stakeholders through multichannel outreach (email, phone, LinkedIn) Profile target accounts to match solution offerings with business needs and regulatory drivers Account Management : Maintain and expand relationships with selected strategic accounts Collaborate across internal teams (marketing, operations, finance, legal) to support growth objectives Cross-functional Collaboration : Work closely with marketing to follow up on leads and align go-to-market messaging Support the refinement of sales processes, CRM data hygiene, and pipeline forecasting Ideal Candidate Profile: Proven track record of enterprise or B2B sales success in life sciences software or data services Strong understanding of clinical trial processes Experience working with Salesforce (or similar CRM platform) Confident selling into a mix of emerging biotech, global pharma, and CRO environments Degree educated - preferably in a scientific, technical, or commercial field Comfortable working independently in a remote environment and willing to travel occasionally
Jul 17, 2025
Full time
Sales Director - Life Sciences SaaS (Remote, UK) A rapidly scaling, innovation-driven SaaS provider within the life sciences sector is looking to appoint a Sales Director to drive new business growth across pharma, biotech, and CRO markets. The company offers cutting-edge solutions that enhance clinical trialregulatory compliance. This is a remote-first role open to UK-based candidates, with occasional international travel. Key Responsibilities: New Business Development : Identify, qualify, and close new business opportunities within pharma, biotech, and CRO sectors Map and engage key stakeholders through multichannel outreach (email, phone, LinkedIn) Profile target accounts to match solution offerings with business needs and regulatory drivers Account Management : Maintain and expand relationships with selected strategic accounts Collaborate across internal teams (marketing, operations, finance, legal) to support growth objectives Cross-functional Collaboration : Work closely with marketing to follow up on leads and align go-to-market messaging Support the refinement of sales processes, CRM data hygiene, and pipeline forecasting Ideal Candidate Profile: Proven track record of enterprise or B2B sales success in life sciences software or data services Strong understanding of clinical trial processes Experience working with Salesforce (or similar CRM platform) Confident selling into a mix of emerging biotech, global pharma, and CRO environments Degree educated - preferably in a scientific, technical, or commercial field Comfortable working independently in a remote environment and willing to travel occasionally
About the Company BioTalentis working with a tech-enabled Healthcare Market Research company with global presence. The company has seen steady growth and success since inception in 2000, with particular success last year allowing them to expand the Client Success Team. The Client Success Team supports their pharmaceutical and agency partners to deliver programs that enable them to reach and gather insights from their target HCP audience. Team Leadership: Manage your team's workload Instil a sense of client and project ownership among all team members Provide your team with advice and solutions across client management, research and project management questions and issues; be a sounding board for team members Line management responsibilities including training, mentoring, evaluating employees and assisting in career development; involvement in hiring Identify team members' strengths as well as weaknesses in order to give them the tools and needed training for developing and improving Work closely with senior leaders to address team and client service topics Work in alignment with the Sales teams to drive client expansion, retention and renewal Be a key player in inter-departmental communication Deliver own projects to a high standard, ensuring project goals are achieved on time and within budget, and high client satisfaction ratings are attained Client Management: Primary day-to-day contact for assigned clients and projects Ensure overall client satisfaction by providing a positive experience with effective and timely delivery of all research programs Lead kick offs, status meetings, brainstorming sessions, and strategy meetings to move business forward Understand clients market research needs Define project goals at the onset of each project Proactively provide recommendations across the company's market research services Lead and participate in client facing training sessions for primary market research and analytics platform Provide insightful recommendations to client's business questions Research: Ensure that the research methodology, instruments, and vendors for each assigned project are the best fit for achieving results Fully understand the client's business and project objectives for each assigned study Evaluate and optimize quantitative surveys created internally and externally Evaluate source data quality and accuracy; identify and resolve issues independently, escalate to client or internally when required Ensure tab spec for DP meets needs to deliver against project objectives; create tab spec as required Prepare reports developed from the research data collected when required Ensure agreed client deliverables meet project objectives, including dashboards, data files Please apply if you have similar experience in Healthcare Provider or Pharma Market Research and Analytics/HealthTech. Remote-first within the United States, option to work in Manhattan, NYC office if preferred. Unfortunately, the company cannot offer visa sponsorship.
Feb 07, 2025
Full time
About the Company BioTalentis working with a tech-enabled Healthcare Market Research company with global presence. The company has seen steady growth and success since inception in 2000, with particular success last year allowing them to expand the Client Success Team. The Client Success Team supports their pharmaceutical and agency partners to deliver programs that enable them to reach and gather insights from their target HCP audience. Team Leadership: Manage your team's workload Instil a sense of client and project ownership among all team members Provide your team with advice and solutions across client management, research and project management questions and issues; be a sounding board for team members Line management responsibilities including training, mentoring, evaluating employees and assisting in career development; involvement in hiring Identify team members' strengths as well as weaknesses in order to give them the tools and needed training for developing and improving Work closely with senior leaders to address team and client service topics Work in alignment with the Sales teams to drive client expansion, retention and renewal Be a key player in inter-departmental communication Deliver own projects to a high standard, ensuring project goals are achieved on time and within budget, and high client satisfaction ratings are attained Client Management: Primary day-to-day contact for assigned clients and projects Ensure overall client satisfaction by providing a positive experience with effective and timely delivery of all research programs Lead kick offs, status meetings, brainstorming sessions, and strategy meetings to move business forward Understand clients market research needs Define project goals at the onset of each project Proactively provide recommendations across the company's market research services Lead and participate in client facing training sessions for primary market research and analytics platform Provide insightful recommendations to client's business questions Research: Ensure that the research methodology, instruments, and vendors for each assigned project are the best fit for achieving results Fully understand the client's business and project objectives for each assigned study Evaluate and optimize quantitative surveys created internally and externally Evaluate source data quality and accuracy; identify and resolve issues independently, escalate to client or internally when required Ensure tab spec for DP meets needs to deliver against project objectives; create tab spec as required Prepare reports developed from the research data collected when required Ensure agreed client deliverables meet project objectives, including dashboards, data files Please apply if you have similar experience in Healthcare Provider or Pharma Market Research and Analytics/HealthTech. Remote-first within the United States, option to work in Manhattan, NYC office if preferred. Unfortunately, the company cannot offer visa sponsorship.