Senior Director, Regulatory Affairs

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 :

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.

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