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.
...Experience: Minimum of 5 years in phlebotomy, including pediatric, geriatric, and capillary collections. At least 3 years in a Patient Service Center (PSC) or In-Office Phlebotomy (IOP) environment they were preferred. Customer service experience in a retail or...
...About the Job The Office Coordinator is responsible for ensuring the smooth operation... ...of daily office activities, front desk management, vendor coordination, facility upkeep, security... ...benefits that include: ~ Medical, Dental, Life Insurance and Employee Assistance...
...This is a hybrid role with 50% on-site requirement in Wilmington, MA . We are seeking a skilled MuleSoft Developer to design, develop, and implement enterprise integration solutions using the MuleSoft Anypoint Platform. The ideal candidate will have strong experience...
ERSG is looking to hire a Crewing Assistant for a global maritime services company in Providence, RI. Title: Crewing Assistant Location: Providence, RI Job type: Contract, full time (on-site) Duration: 6-12 months with possibility of extensions Benefits...
...Job Title: Junior Machine Learning Engineer Exp: 1-4 years(Entry level) What This Role Requires: ~1-4 years of data analyst/ML/AI engineering work experience after your degree. ~ Must have experience with both Python programming & SQL language developer. ~ Should...