A leading global biopharmaceutical organisation with an established and growing vaccine portfolio, who are seeking a Head of Regulatory Affairs to lead global and regional regulatory strategy across development, licensure, and post-approval lifecycle management. This role reports into the SVP, R&D and will collaborate closely with R&D, Clinical, Quality, Manufacturing, and Commercial functions to drive product success across multiple markets.
Key Responsibilities
- Provide strategic leadership across all Regulatory Affairs functions, including CMC, Development, Post-Authorisation, EU & International Markets, North America, Partner Markets, Regulatory Operations, and Labelling.
- Develop and execute global regulatory strategies from preclinical through post-marketing stages.
- Advise senior leadership on regulatory pathways, opportunities, and risks.
- Represent the organisation in interactions with major health authorities (e.g., FDA, EMA, MHRA, WHO).
- Oversee the preparation and timely submission of high-quality regulatory filings (INDs, BLAs/MAAs, amendments, and variations).
- Monitor regulatory intelligence and assess potential business or process impacts.
- Embed regulatory considerations into development programs, including clinical plans, manufacturing, tech transfers, scale-up, and labelling.
- Build, develop, and mentor a high-performing Regulatory Affairs team, delivering across multiple priority programs in parallel.
- Lead post-approval regulatory activities and ensure ongoing global compliance.
Qualifications
- Advanced degree in a scientific, medical, or regulatory discipline (PhD, PharmD, MD, or MSc preferred).
- 15+ years’ experience in Regulatory Affairs within biotech, pharma, or vaccines, including 5+ years in senior leadership. Experience across vaccines and/or biologics strongly preferred.
- Demonstrated success leading major regulatory submissions and approvals.
- Strong knowledge of U.S. and EU regulatory frameworks; additional global market experience is an advantage.
- Excellent leadership, communication, and stakeholder-management capability.
- Proven ability to balance innovation, compliance, and risk in a complex, cross-functional environment.