Senior Vice President, Regulatory Affairs
Confidential
Senior Vice President, Regulatory Affairs
About the Company
Novel, rapidly growing clinical-stage biotechnology company advancing medicines toward approval and commercialization
Industry
Biotechnology
Type
Public Company
About the Role
The Company is seeking an SVP/Global Head of Regulatory Affairs to take on a pivotal senior leadership role. The successful candidate will be the company's most senior regulatory leader, responsible for defining and driving global regulatory strategy across the clinical development pipeline. This includes serving as the primary regulatory interface with the FDA and other global health authorities, leading critical meetings, and providing strategic leadership for all regulatory submissions. The role also involves building and leading a scalable regulatory affairs organization, partnering with cross-functional teams to align regulatory strategy with development plans and business objectives, and anticipating and advising on evolving regulatory requirements, particularly for novel therapeutic modalities. Applicants for the SVP/Global Head of Regulatory Affairs position at the company should have a minimum of 15 years' of progressive regulatory affairs experience in the biotechnology or pharmaceutical industry, with a strong background in immunology, inflammation, or a related specialty area. The ideal candidate will have a proven track record in leading regulatory strategy from IND through late-stage development and registration, with experience in NDA/BLA or MAA submissions. Direct, senior-level experience with the FDA and other major global health authorities is essential. The role requires a leader with the ability to build and scale high-performing regulatory teams, strong executive presence, and excellent communication skills to advise C-suite leadership and Boards on complex regulatory matters. Experience with novel or first-in-class therapeutic modalities and a background in supporting partnered programs or regulatory governance with pharmaceutical collaborators are highly valued.
Hiring Manager Title
CMO
Functions
- Legal
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