Senior Vice President, Global Regulatory Affairs

Senior Vice President, Global Regulatory Affairs

About the Company

Clinical-stage biotechnology company pioneering next-generation precision oncology therapeutics and accelerated global registration.

Industry
Biotechnology

Type
Privately Held, VC-backed

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 pipeline. 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 accelerated and expedited pathways. The SVP will oversee all interactions with global health authorities, guide registration pathways for therapeutics and associated enabling technologies, and ensure the infrastructure is in place for eventual commercialization. Collaboration with cross-functional teams, including translational sciences, clinical development, and external partners, is essential, as is the ability to mentor and build a high-performing global regulatory team. Applicants must have a minimum of 15 years of regulatory experience in the biopharmaceutical industry, with a focus on global oncology. Extensive expertise in oncology regulatory affairs, particularly in the context of late-stage development, is a prerequisite. The ideal candidate will have a successful history with accelerated and expedited regulatory programs, including those with the FDA and EMA. 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 establishing and maintaining regulatory systems, processes, and documentation standards, as well as ensuring inspection readiness and compliance as the organization progresses toward pivotal trials.

Travel Percent
Less than 10%

Functions

• Business Development