A privately held, clinical-stage biotechnology company is seeking a Vice President / Head of Regulatory Affairs to join its leadership team. This role will be pivotal in shaping and executing global regulatory strategies to support the development of novel therapies targeting neurological and neuroinflammatory conditions.
The company is advancing a pipeline of small molecule candidates aimed at addressing unmet needs in complex diseases of the nervous system. The environment is fast-paced, mission-driven, and highly collaborative.
Key Responsibilities
- Lead the development and execution of global regulatory strategies across early and mid-stage clinical programs
- Oversee regulatory submissions including INDs, CTAs, briefing packages, and designation requests
- Serve as the primary liaison with global health authorities (FDA, EMA, etc.)
- Provide strategic regulatory guidance to cross-functional teams including clinical, R&D, manufacturing, and quality
- Monitor regulatory trends and ensure compliance across programs
- Manage external regulatory consultants and vendors
- Build and mentor a high-performing regulatory team
Qualifications
- Advanced degree in a scientific discipline (PharmD, PhD, MD preferred)
- 12+ years of regulatory affairs experience in biotech/pharma, including leadership roles
- Experience with CNS or neuro-related programs is a plus
- Proven success in both large and small company environments
- Strong knowledge of global regulatory requirements and pathways
- Demonstrated success in regulatory submissions and approvals
- Excellent leadership, communication, and cross-functional collaboration skills
Additional Information
- Location: Bay Area preferred
- Competitive compensation package including equity, comprehensive health benefits, and retirement plan
If you are passionate about advancing science in a dynamic, entrepreneurial setting, we encourage you to apply.
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