Job Role: Regulatory Affairs Strategist/Lead
Location: Cambridge (Hybrid)
We are seeking a Regulatory Affairs Strategist to develop and deliver US and European regulatory strategy for clinical-stage programs in selected indications. This role will translate scientific, clinical, and product-development plans into practical regulatory pathways, provide hands-on regulatory leadership, and partner closely with cross-functional teams to ensure regulatory requirements are built into development decisions from the outset.
Key Responsibilities
- Develop and execute US and European regulatory strategy for clinical-stage programs, from early development through pivotal studies and marketing authorization preparation.
- Own regulatory project management and timelines, working hands-on with responsibility for day-to-day delivery of regulatory activities.
- Lead and coordinate the preparation, review, and lifecycle management of regulatory submissions to the FDA, EMA, and other health authorities, including INDs and CTAs.
- Provide regulatory leadership on dossier strategy and content planning, including relevant elements of the Common Technical Document.
- Work with functional authors and external vendors to ensure regulatory documents are accurate, consistent, scientifically robust, and submitted on time.
- Lead or co-lead the planning, preparation, and execution of health authority meetings, including Scientific Advice, pre-IND, and End of Phase 2 meetings, as well as written interactions with agencies.
- Co-lead Joint Clinical Assessment (JCA) strategy and execution for indications in scope.
- Advise program teams on the regulatory implications of clinical development decisions.
- Monitor the changing regulatory landscape, competitor precedents, and emerging guidance that could affect program strategy.
Qualifications & Experience
- MSc, PhD, PharmD, or MD in life sciences, pharmacy, medicine, or a related scientific discipline.
- Ideally 5 to 10 years of regulatory affairs experience within biotechnology, pharmaceutical development, consultancy, or a regulatory authority, with meaningful clinical development experience up to and including Phase 3.
- Demonstrated experience developing and executing regulatory strategies for investigational medicinal products across the US and Europe.
- Experience preparing or leading components of clinical trial applications and other development-stage submissions.
- Proven experience supporting or leading health authority interactions, including meeting preparation and interpretation of agency advice.
- Strong understanding of drug development, including clinical, nonclinical, and safety.
- Working knowledge of ICH guidelines, EU Clinical Trials Regulation, US clinical trial requirements, GCP, and CTD principles.
- Excellent problem-solving, organizational, and communication skills, with the ability to work independently in a fast-paced environment. Preferred Experience
- Regulatory strategy experience in the UK and Japan.
- Understanding of CMC, ex-US market access, and Health Technology Assessment requirements.
- Experience in rare disease or immunology clinical development.
- Experience working in smaller or growth-stage organizations with evolving processes.
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Contact Details:
Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment Recruitment Team
