Vice President Regulatory Affairs

Role: Vice President / Senior Vice President, Regulatory Affairs

Our client is a well-funded, clinical-stage biotechnology company advancing innovative therapies for autoimmune, dermatologic, and inflammatory diseases with significant unmet medical need. Following a successful recent financing and strong Phase 2 clinical data, the organization is entering an important period of growth, with Phase 3 development, registration-enabling activities, and future BLA submissions ahead.

The culture is highly collaborative, respectful, and low ego. Leadership sets a high bar while maintaining a people-first environment where employees are trusted to take ownership, work cross-functionally, and contribute ideas regardless of title. This is a high-performing team of doers who are deeply committed to the company’s mission and success.

Our client is seeking a Vice President or Senior Vice President of Regulatory Affairs to lead the function through its next stage of growth and ultimately take ownership of the company’s global regulatory strategy. This individual will guide late-stage programs through Phase 3, registration, and pre-commercial milestones while building the team, infrastructure, and regulatory capabilities needed to support continued growth.

• Lead global regulatory strategy across late-stage programs, including Phase 3, registration-enabling activities, and future BLA/NDA submissions.
• Serve as a senior strategic partner to executive leadership and cross-functional teams on development plans, trial design, endpoints, labeling, and health authority strategy.
• Lead interactions with global regulatory authorities, with particular emphasis on the FDA, EMA, and Health Canada, while overseeing external regulatory partners and vendors.
• Build and evolve the Regulatory Affairs function, including team structure, processes, infrastructure, and long-term organizational strategy.

• 15+ years of progressive Regulatory Affairs experience within biotechnology or pharmaceuticals, with significant late-stage development experience.
• Demonstrated experience leading or playing a central role in BLA and/or NDA submissions and pre-launch regulatory activities.
• Strong global regulatory experience, particularly across the U.S. and Europe, with experience navigating complex or nontraditional regulatory pathways.
• Proven senior leadership experience with the ability to build teams, influence executives, and remain hands-on in a growing biotech environment.

This position is expected to be onsite in the Greater Boston/Waltham area Tuesday through Thursday.