Senior Vice President, Global Regulatory Affairs
Confidential
Senior Vice President, Global Regulatory Affairs
About the Company
Clinical-stage biotechnology company pioneering next-generation 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, with a focus on oncology. The successful candidate will be the senior-most regulatory leader, tasked with developing and driving global regulatory strategy from early development to post-marketing planning. This role is pivotal in leading regulatory interactions with global health authorities, particularly in the context of the company's innovative approach to precision oncology therapeutics. The SVP will be responsible for shaping the regulatory vision, overseeing registration pathways, and building the necessary infrastructure for commercialization. A hands-on, innovative regulatory executive with a proven track record in late-stage oncology drug development and experience in accelerated regulatory pathways is essential. Applicants must have a minimum of 15 years' regulatory experience in the biopharmaceutical industry, with a strong background in global oncology regulatory strategies. The role requires a leader who is comfortable in a fast-paced environment and has a successful history with expedited programs, including FDA and EMA interactions. Experience in leading regulatory strategy for programs involving novel biomarkers, diagnostics, or patient-selection tools is a plus. The SVP will also be responsible for mentoring a global regulatory team, establishing regulatory systems and processes, and ensuring compliance as the organization progresses toward pivotal trials. Exceptional communication skills, scientific fluency, and the ability to translate complex data into regulatory strategy are crucial for this position.
Functions
- Business Development
- Medical Care/Hospital Administration
Vacancy posted 3 days ago
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