Head of Regulatory Affairs
Company: Warman O'Brien Agency
- Location: London, United Kingdom
- Work mode: Hybrid
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Head of Regulatory Affairs – CNS / Gene Therapy
Remote / Hybrid – UK or USA
Warman O’Brien are proud to partner with an innovative, clinical stage biotechnology company seeking an experienced Head of Regulatory Affairs to lead global regulatory strategy across a late-stage gene therapy programme and support the company's expanding development pipeline.
Responsibilities:
- Lead global regulatory strategy across late-stage gene therapy development programmes
- Drive regulatory interactions with the FDA, EMA and PMDA
- Provide strategic input into clinical trial design, regulatory development plans and submission strategies
- Oversee regulatory submissions and ensure alignment with global regulatory requirements
- Collaborate closely with clinical development, medical leadership and cross-functional teams
- Provide regulatory expertise to support business development, asset evaluation and future in-licensing opportunities
- Manage external regulatory consultants and support the development of the internal regulatory function
Experience required:
- Extensive regulatory affairs experience within biotechnology or pharmaceutical drug development
- Direct CNS experience is essential, ideally within neurodegenerative diseases
- Previous gene therapy experience is essential, with AAV experience advantageous
- Strong FDA regulatory strategy and agency interaction experience
- Experience with EMA and PMDA regulatory pathways
- Experience supporting late-stage clinical development, ideally Phase III programmes
- Previous BLA / MAA submission or approval experience advantageous
- Experience working in smaller biotechnology environments, with the ability to operate both strategically and hands-on
- Working knowledge of medical device regulations
- Excellent leadership, communication and stakeholder management skills
If you are interested in finding out more, please click apply!
