Regulatory Affairs
Vice President, Regulatory Affairs
Lead regulatory strategy for a marketed biologic in dermatology and its expansion into new inflammatory indications. This role carries the agency relationship and the lifecycle plan.
A typical mandate
The company markets a monoclonal antibody for a chronic inflammatory skin disease and is running studies in two additional indications. A supplemental BLA is planned within the next 18 months. Regulatory now needs one leader to align lifecycle, labeling and new indication strategy.
What the role owns
- Own regulatory strategy for the marketed product and all supplemental indications
- Lead preparation and submission of the planned sBLA, including labeling negotiations
- Serve as primary contact with the FDA review division
- Oversee advertising and promotional review in partnership with legal and medical
- Maintain post-marketing commitments, annual reports and safety reporting interfaces
- Lead and develop a team of regulatory strategists, operations and labeling specialists
What great candidates bring
- Advanced degree (PhD, PharmD or MS) in a scientific discipline
- 15+ years in regulatory affairs, with leadership of BLA or sBLA submissions
- Experience with a marketed biologic, including labeling and OPDP interactions
- Immunology or dermatology background strongly preferred
- Track record of leading FDA meetings and negotiating label language
- Experience managing people managers
Why it matters
- Reports to the Chief Development Officer, with visibility to the executive team
- Annual bonus and long-term incentives at a commercial-stage company
- Scope across lifecycle, labeling and new indications
- Hybrid schedule, typically three days a week on site
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