Vice President / Head of Regulatory Affairs – Biotech
Boston, MA
We are seeking a Vice President / Head of Regulatory Affairs to lead regulatory strategy for a growing clinical-stage biotech. This role is ideal for a hands-on regulatory leader who can operate as both strategist and builder, shaping regulatory direction while standing up a function in a lean, fast-moving environment.
Key Responsibilities
- Lead global regulatory strategy across the company’s pipeline, with responsibility from early development through key clinical and potential registration milestones.
- Serve as the company’s regulatory lead, driving strategy for INDs, health authority interactions, briefing documents, amendments, and longer-term development plans.
- Provide strategic input on regulatory pathways, agency engagement strategy, and opportunities to accelerate development.
- Act as a key cross-functional partner to Clinical, CMC, Nonclinical, and executive leadership, ensuring regulatory strategy is integrated into broader program decisions.
- Lead and prepare for FDA and global health authority meetings, including ownership of meeting strategy, briefing packages, and agency responses.
- Build and scale the regulatory function, initially operating in a hands-on capacity while leveraging consultants and external partners as needed.
- Assess regulatory risks proactively and help shape development decisions at both the asset and portfolio level.
- Support corporate strategy through diligence, partnering discussions, and Board or investor interactions as needed.
Qualifications
- Bachelor’s degree in a scientific discipline required; advanced degree (PhD, PharmD, MS or equivalent) preferred.
- 12+ years of regulatory affairs experience in biotech or pharma, including meaningful experience leading regulatory strategy for development-stage programs.
- Demonstrated experience authoring or leading IND submissions and managing direct interactions with FDA.
- Strong understanding of early and mid-stage development, including regulatory strategy through proof-of-concept and beyond.
- Prior experience in oncology, rare disease, immunology, or other relevant therapeutic areas preferred.
- Experience supporting emerging biotech companies, whether in-house or in highly collaborative environments, strongly preferred.
- Prior experience building or leading a regulatory function, or operating as the senior-most regulatory leader within a small company, preferred.
- Comfort operating in a hands-on, resource-constrained environment where both strategy and execution are expected.