Director, Regulatory Affairs
About The Position
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: The Director, Regulatory Affairs will lead global regulatory strategy for development-stage neuroscience programs. This individual will serve as the regulatory lead on cross-functional teams and be responsible for developing and implementing global regulatory strategies that support the advancement of product candidates from early development through approval. The ideal candidate is a collaborative, strategic thinker with a strong understanding of global regulatory requirements for neurological and psychiatric therapies.
Requirements
- Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field preferred.
- Minimum of 10 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with a focus on clinical-stage products.
- Strong understanding of global regulatory frameworks (e.g., FDA, EMA, ICH).
- Proven ability to influence cross-functional teams and drive strategic outcomes.
- Excellent written and verbal communication skills.
- Ability to work independently and thrive in a fast-paced, evolving environment.
Nice To Haves
- Experience in regulatory strategy for neuroscience or CNS therapeutics is highly preferred.
- Demonstrated success leading regulatory submissions and interactions with global health authorities.
Responsibilities
- Works with the Sr Director, Regulatory Affairs to develop and direct innovative and effective regulatory strategies in support of assigned MapLight portfolio projects.
- Provides advice on regulatory issues and actively collaborates with cross-functional team members, e.g., Clinical Pharmacology, Toxicology, Research, Clinical Development, Biostats, Data Management, Quality, CMC, Pharmacovigilance, Medical Writing, Commercial, publishing vendor, consultants, etc.
- May represent MapLight as point of contact with FDA and provides support for and coordination of regulatory meetings and briefing document development.
- Provide regulatory guidance on clinical development plans, CMC strategies, and nonclinical programs to ensure regulatory alignment.
- Lead or oversee the preparation and submission of regulatory documents, including INDs/CTAs, meeting packages, orphan drug applications, and other global regulatory filings.
- Interpret and communicate regulatory requirements and risks to internal teams and senior leadership.
- Monitor changes in the regulatory landscape relevant to neuroscience and provide strategic advice to adapt plans accordingly.
- Collaborate with external partners, consultants, and regulatory agencies to advance development programs.
Benefits
- Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
51-100 employees
