Vice President and Senior Vice President, Global Regulatory Affairs

Vice President and Senior Vice President, Global Regulatory Affairs

About the Company

Esteemed biotechnology company developing 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 to spearhead the regulatory strategy for its innovative oncology pipeline. The successful candidate will be the senior-most regulatory leader, with a focus on shaping, executing, and scaling global regulatory strategy from early development to post-marketing planning. This role is pivotal in leading regulatory interactions with global health authorities, guiding registration pathways for therapeutics and associated enabling technologies, and building the necessary infrastructure for commercialization. The ideal candidate will be a hands-on regulatory innovator, particularly in the areas of precision medicine, biomarkers, and accelerated regulatory pathways, and will thrive in a fast-moving clinical environment. Applicants must have a minimum of 15 years of regulatory experience in the biopharmaceutical industry, with a strong background in leading global regulatory strategy for late-stage oncology drug development. A successful track record with accelerated and expedited pathways, including FDA and EMA interactions, is essential. Experience in leading regulatory strategy for programs involving novel biomarkers, diagnostics, or patient-selection tools is a plus. The role requires exceptional communication skills, scientific fluency, and the ability to translate complex data into regulatory strategy. The SVP will also be responsible for building and mentoring a high-performing global regulatory team, establishing regulatory systems and processes, and ensuring inspection readiness and compliance as the organization progresses toward pivotal trials.

Travel Percent
Less than 10%

Functions

• Operations
• Strategy