Director, Regulatory Affairs

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.

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.

Qualifications:

• 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.
• Experience in regulatory strategy for neuroscience or CNS therapeutics is highly preferred.
• Demonstrated success leading regulatory submissions and interactions with global health authorities.
• 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.

Location: Remote US position.  This is a hybrid in office position if you are located within 50 miles of either Redwood City, CA or Burlington, MA.   

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.