Head of Regulatory Affairs

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!