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 the integration of precision medicine and accelerated regulatory pathways. This role demands a hands-on regulatory innovator with a proven track record in leading global oncology regulatory strategies, including interactions with major health authorities. The VP/SVP will be responsible for all aspects of regulatory planning, from early development to post-marketing, and must be adept at leading a high-performing global regulatory team. Applicants must have a minimum of 15 years' regulatory experience in the biopharmaceutical industry, with a strong background in late-stage oncology drug development and a successful history with accelerated and expedited regulatory programs. The role requires exceptional communication skills, scientific fluency, and the ability to work in a fast-paced, collaborative environment. Experience in leading regulatory strategy for programs involving novel biomarkers, diagnostics, or patient-selection tools is a plus. The ideal candidate will be a strategic leader, capable of providing direction for regulatory pathways and ensuring compliance as the organization progresses toward pivotal trials.

Functions

• Operations