Vice President, Regulatory Affairs

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 US 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