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 Senior Vice President for Global Regulatory Affairs, with a focus on oncology. The successful candidate will be the senior-most regulatory leader, tasked with developing and driving global regulatory strategy from early development to post-marketing planning. This role is pivotal in leading regulatory interactions with global health authorities, particularly for programs seeking accelerated approval and those involving innovative precision medicine frameworks. The ideal candidate will have a hands-on approach, be a regulatory innovator, and have a proven track record in leading global oncology regulatory strategies. Key responsibilities for the SVP, Global Regulatory Affairs include overseeing regulatory documentation and submissions for late-stage development, providing strategic direction for regulatory pathways involving patient-selection tools and assays, and building a high-performing global regulatory team. The role demands a leader who can ensure inspection readiness and compliance as the organization progresses toward pivotal trials. Applicants must have a minimum of 15 years of regulatory experience in the biopharmaceutical industry, with a strong emphasis on late-stage oncology drug development. Experience in leading regulatory strategy for programs involving novel biomarkers and diagnostics is a plus, as is a successful track record with accelerated and expedited regulatory pathways. The candidate should be comfortable in a fast-paced environment and possess exceptional communication skills, scientific fluency, and the ability to translate complex data into regulatory strategy.

Travel Percent
Less than 10%

Functions

• Business Development