Senior Vice President, Global Regulatory Affairs

Senior Vice President, Global Regulatory Affairs

About the Company

Clinical-stage biotechnology company with a broad multi-asset portfolio across multiple therapeutic areas

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is seeking a senior global regulatory affairs executive to shape and lead regulatory strategy across a diverse, maturing development portfolio. The role oversees regulatory planning from early development through registration and post-marketing, including expedited and rare-disease pathways. Responsibilities include leading health-authority interactions, guiding late-stage submissions and pivotal study planning, and advising executive leadership on regulatory strategy. The executive will prioritize resources across programs, collaborate with scientific and development teams, build and mentor a global regulatory team, and establish systems that support compliance and inspection readiness. Candidates should have at least 15 years of regulatory experience in the biopharmaceutical industry, including leadership of global strategy and hands-on experience with late-stage drug development. Experience spanning multiple therapeutic areas is required, with direct experience in at least two relevant areas strongly preferred. A successful record guiding programs from Phase 2 through registration and working with expedited pathways and international health authorities is essential. Strong communication skills, scientific fluency, and the ability to translate complex data into clear regulatory strategy are required; experience with both small molecules and biologics is an advantage.

Functions

• Business Development