Regulatory Affairs Strategist/Lead

About the job

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.

To Apply In the first instance please send your resume and any relevant supporting details for consideration to: william.hinton@morganprestwich.com