Senior Vice President, Global Regulatory Affairs

Senior Vice President, Global Regulatory Affairs

About the Company

A clinical-stage biotechnology company pioneering next-generation precision oncology therapeutics.

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is in search of a Vice President/Senior Vice President for Global Regulatory Affairs, with a focus on oncology. The successful candidate will be at the forefront of shaping and executing the global regulatory strategy for a maturing oncology pipeline, with a particular emphasis on late-stage development. This role demands a seasoned regulatory executive with a hands-on approach, capable of leading the team in interactions with global health authorities and guiding registration pathways for both therapeutics and associated enabling technologies. The ideal candidate will have a proven track record in driving regulatory strategy for late-stage oncology drug development, including experience with accelerated and expedited pathways, and a deep understanding of the regulatory landscape for precision medicine and biomarkers. Key responsibilities for the VP/SVP include developing and driving global regulatory strategy, leading regulatory planning for programs pursuing accelerated approval, and serving as the primary regulatory voice to executive leadership and the Board. The role also involves overseeing regulatory documentation and submissions, providing strategic direction for regulatory pathways, and building a high-performing global regulatory team. The candidate should have at least 15 years of regulatory experience in the biopharmaceutical industry, with a strong background in global oncology regulatory strategies, and a successful history of working with FDA and EMA programs. Exceptional communication skills, scientific fluency, and the ability to mentor and scale a regulatory team are essential for this position.

Functions

• Business Development