Senior Vice President, Global Regulatory Affairs

Senior Vice President, Global Regulatory Affairs

About the Company

Clinical-stage biotechnology company with a multi-asset pipeline across oncology, neuroscience, immunology, and rare disease

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 lead the strategic and operational aspects of regulatory activities across a diverse and advancing multi-therapeutic-area pipeline. The successful candidate will be the senior-most regulatory leader, responsible for developing and driving global regulatory strategy from early development through to post-marketing planning. This role demands a hands-on approach, with a focus on leading regulatory planning for programs in various stages, including those pursuing accelerated approval and orphan/rare disease frameworks. The VP/SVP will also be the primary regulatory contact for executive leadership and Board-level stakeholders, and will oversee all interactions with global health authorities, including the FDA, EMA, and PMDA. Applicants must have a minimum of 15 years' regulatory experience in the biopharmaceutical industry, with a proven track record in leading global regulatory strategy. The role requires a leader who is comfortable in a fast-paced, resource-conscious environment and has a successful history with accelerated/expedited pathways. Experience in multiple therapeutic areas is essential, with a strong preference for direct experience in oncology, neuroscience, immunology, or rare disease. The ideal candidate will have a background in both small molecule and biologics, exceptional communication skills, and the ability to mentor and build a high-performing global regulatory team. The position is pivotal as the organization prepares for the commercialization of its late-stage assets, and the VP/SVP will be instrumental in ensuring inspection readiness and compliance throughout the process.

Functions

• Business Development