Senior Vice President, Global Regulatory Affairs

Senior Vice President, Global Regulatory Affairs

About the Company

Clinical-stage biotechnology company pioneering 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 to lead the regulatory vision for its innovative oncology therapeutics. The successful candidate will be the senior-most regulatory leader, responsible for developing and driving global regulatory strategy from early development to post-marketing planning. This role demands a hands-on regulatory innovator with a proven track record in global oncology regulatory strategies, particularly in the context of late-stage development and accelerated approval pathways. The SVP will be the primary regulatory voice for executive and Board-level stakeholders, overseeing all interactions with global health authorities and guiding registration pathways for both therapeutics and associated enabling technologies. Applicants must have a minimum of 15 years' regulatory experience in the biopharmaceutical industry, with a focus on oncology, and a successful history of leading regulatory strategy for programs involving novel biomarkers and patient-selection tools. The role requires exceptional communication skills, scientific fluency, and the ability to mentor and build a high-performing global regulatory team. The ideal candidate will be adept at collaborating with cross-functional teams, including translational sciences, clinical development, and commercial planning, to ensure alignment in drug and diagnostic development. The position is pivotal as the organization moves toward pivotal trials, and the SVP will be instrumental in establishing regulatory systems, processes, and documentation standards that meet late-stage expectations.

Functions

• Business Development
• Medical Care/Hospital Administration