VP Regulatory Affairs

The role

The company develops AAV gene therapies for inherited metabolic disorders, with its lead programme in a pivotal Phase 3 trial and two further candidates in Phase 1. Topline data are expected in the second half of next year, followed by a Biologics License Application under Breakthrough Therapy designation. Regulatory work has so far been led by the Chief Medical Officer with support from consultants, and the company now needs a full-time head of the function. You will report to the CMO and join a senior leadership team of 12.

What you will do

• Own global regulatory strategy for the portfolio, starting with the BLA and a parallel marketing authorisation application to the EMA.
• Lead all interactions with the FDA’s Office of Therapeutic Products, including the pre-BLA meeting.
• Build a team of four over the next year across regulatory strategy, CMC and operations.
• Work with manufacturing and quality on the CMC sections, where gene therapy filings most often stall.
• Advise on paediatric plans, expedited pathways and labelling.

What you will bring

• At least 12 years in regulatory affairs, including direct leadership of a BLA or NDA through to approval.
• Experience with cell or gene therapy, or another complex biologic.
• A record of leading FDA meetings yourself, not supporting them.
• Working knowledge of EMA procedures, including PRIME.
• The ability to explain regulatory risk clearly to the board and to investors.

The package

Base of $290,000 to $330,000, a 30% target bonus, an equity grant and full benefits. Three days a week in the Kendall Square office. The process includes a meeting with the CEO and a presentation to the leadership team, and should complete within five weeks.