Mantell Associates
Mantell Associates is partnered with a pioneering precision genetic medicine company focused on novel gene therapies, who is seeking a seasoned Director of Regulatory Strategy to lead and shape regulatory pathways across global markets.
You’ll drive successful regulatory approvals, optimise submission strategies, and influence internal teams to bring groundbreaking therapies to patients.
Director of Regulatory Strategy – Responsibilities:
- Develop and implement global regulatory strategies for gene therapy assets—from preclinical to market approval across major markets (FDA, EMA, MHRA, PMDA, others)
- Provide strategic regulatory guidance on product development plans, IND/IMPD, BLA/MAA filings, and post-marketing requirements
- Advise on CMC, nonclinical, clinical, and pharmacovigilance regulatory elements in close collaboration with cross-functional teams (R&D, CMC, Clinical, Safety, Quality, Commercial)
- Lead dialogue with global regulatory authorities—prepare briefing documents, lead agency meetings, and respond to regulator feedback
- Map regulatory frameworks and pipeline opportunities by region (e.g., orphan drug designations, PRIME, RMAT, Breakthrough Therapy)
- Provide leadership on complex issues: vector design, biodistribution, immunogenicity, long-term safety, comparability, and manufacturing control
- Mentor and build capability of internal regulatory strategy team; foster cross-functional regulatory excellence and awareness
- Monitor evolving regulatory trends in gene therapy; steer proactive strategy adjustments to secure approvals and minimize delays
Director of Regulatory Strategy – Requirements:
- Advanced degree (Pharma Sciences, Molecular Biology, Regulatory Affairs); PhD preferred
- 10 years of regulatory affairs experience in biologics and/or advanced therapies; minimum 5 years focused on gene therapy
- Proven record in successful global regulatory filings: IND/CTA, BLA/MAA, NDA, including rare/orphan designations
- In-depth knowledge of regulatory frameworks for ATMPs, including gene editing technologies, viral vectors, and gene-modified cell therapies
- Strong scientific acumen with excellent strategic and technical writing ability
- Experience representing companies in regulatory agency meetings (e.g. FDA, EMA pre-IND/IMPD, Type C, Scientific Advice, EU PDCO)
- Superb leadership and communication skills with ability to influence senior stakeholders
- Global mindset and willingness to travel internationally
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at 44 (0)20 3854 7700.