Senior Director, Regulatory Affairs

Mission Bay, San Francisco, CA – full-time, on-site

GABAeron, Inc. is a biopharmaceutical company focusing on the development of therapies using stem cells to treat neurological diseases, such as Alzheimer’s disease. GABAeron takes a novel approach that combines precision medicine (using genetic information for patient stratification) with regenerative medicine (using human iPSC-derived cell products for therapy). The therapeutic programs of GABAeron are specifically designed to replace or protect some of the most vulnerable brain cell populations, restoring and preserving brain functions in patients with genetically defined neurological diseases using human iPSC-derived cell products.

Job Description

The Senior Director of Regulatory Affairs will lead the company’s regulatory strategy and execution, providing leadership and oversight for product development to support the IND and early clinical trial application and studies. Serve as the company’s regulatory expert, driving the preparation and submission of regulatory filings, establishing and maintaining relationships with health authorities, and ensuring adherence to evolving standards.

The successful candidate will bring a deep expertise in regulatory science, a strong understanding of cell therapy and neuroscience programs, and an ability to guide a cross-functional team through preclinical development toward first-in-human studies.

Key Responsibilities

Regulatory Strategy and Leadership

• Provides strategic and scientific leadership to ensure development plans align with regulatory requirements and position programs for a successful IND submission
• Develop and execute regulatory strategies and internal procedures to advance preclinical efficacy studies and clinical trial readiness
• Serve as the principal regulatory liaison with the FDA, EMA, and other health authorities
  
  
  

Regulatory Operations and Submissions

• Plan, prepare, and review regulatory submissions, including INDs, CTAs, amendments, and related correspondence
• Lead regulatory meetings, coordinate documentation, and follow up with agencies
• Manage timelines and deliverables to ensure high-quality submissions that meet program deadlines. Maintain records and compliance documentation for all regulatory interactions
  
  
  

Cross-Functional Collaboration

• Partner closely with the internal and CMC teams to ensure scientific and regulatory alignment
• Coordinate with the external CRO and collaborators, supporting cell product manufacturing and development
• Establish internal procedures for regulatory operations, ensuring continuous process improvement and institutional readiness
  
  
  

Leadership and Development

• Provide mentorship and regulatory training to scientific staff
• Help build a culture of compliance, transparency, and operational excellence
• Monitor, analyze, and communicate evolving developments that may affect ongoing and future programs
  
  
  

Required Qualifications And Experience

• MD or PhD, or a Master’s Degree with extensive experience
• A minimum of 8 years in regulatory affairs with 12 years in the biotech/pharma industry, including experience in leadership roles
• Proven experience leading successful IND and clinical trial applications
• Demonstrated success in regulatory agency interactions and meetings
• Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
• Thorough knowledge of US and international regulations, standards, and guidance documents
• Experience in cell therapy and the neurosciences
• Ability to thrive in a dynamic, collaborative, cross-functional environment
• Proficient at creating and communicating a clear vision among team members
• Strategic mindset with the ability to integrate scientific, clinical, and regulatory perspectives
  
  
  

Salary Range: $195,000 - $245,000

• Please note: Compensation and leveling will be commensurate with experience and expertise and could fall outside of the stated range
  
  
  

In Addition To Competitive Salaries, GABAeron Offers The Following

• Equity Medical, Dental & Vision Plan Options
• Short-Term and Long-Term Disability
• Group Life Insurance
• FSA Plans (medical, dependent daycare, and commuter)
• Employee Assistance Program (EAP)
• 401k Plan
  
  
  

GABAeron provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.