Director, Regulatory CMC

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: We are seeking an experienced and strategic Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) to lead the development and execution of global regulatory CMC strategies for our growing pipeline of innovative therapeutics. The successful candidate will play a critical role in ensuring timely development and registration of our products by providing global CMC regulatory guidance and leading applicable interactions with regulatory agencies. This is a highly collaborative role that partners closely with regulatory strategy, CMC, and quality teams to support overall product and clinical development.

Responsibilities:

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and post-approval) in alignment with program objectives and regulatory requirements.
• Represents the regulatory function on cross-functional CMC product development project teams and with external partners/vendors, as needed.
• Lead the preparation, review, and submission of timely and high-quality CMC sections of regulatory filings including INDs, IMPDs, QOSs, NDAs, MAAs, amendments, and health authority responses.
• Ensure regulatory compliance of CMC documentation and activities in collaboration with manufacturing, process development, analytical, and quality teams.
• Manage and maintain awareness of evolving global CMC regulatory requirements and guidelines and communicate implications to internal teams.
• Ensure that project team members, line management, and key stakeholders are promptly and professionally informed of any developments that could impact regulatory outcomes, applying sound judgment throughout.
• Lead the planning and execution of CMC-related engagements with regulatory agencies including identification of need, timing, and questions, authoring briefing documents and preparing team members for participation in health authority meetings to gain alignment on CMC strategies.
• Support due diligence and partnering efforts with regulatory insights and risk assessments pertaining to CMC regulatory matters, if requested.
• Develop and manage direct report(s), facilitating professional growth, and ensuring accountability for project deliverables, if applicable.
• Conduct regulatory impact assessments for change controls related to CMC activities.

Qualifications:

• BS/BA in life sciences, chemistry, pharmacy, or a related discipline; Advanced degree (PhD, MS, or equivalent) preferred.
• Minimum of 10 years of experience in the biotech or pharmaceutical industry with at least 5 years focused on CMC regulatory affairs. Preference for experience within a CMC function (drug substance/drug product development or manufacturing).
• Proven track record of contributing to or leading CMC regulatory strategy and successful submissions to and interactions with global regulatory authorities.
• Demonstrated ability to address high‑priority issues by delivering expert regulatory guidance and making well‑reasoned decisions, even in situations lacking clear or specific regulatory direction.
• Experience with both early- and late-stage development for small molecules.
• In-depth knowledge of ICH, FDA, EMA, and other relevant regulatory guidelines and expectations related to CMC.
• Strong leadership, project management, problem-solving, and interpersonal skills with the ability to work in a fast-paced, collaborative environment.
• Excellent written and verbal communication skills, including experience writing regulatory documents.

Location:

This is a hybrid position located at our office in Burlington, MA.

Travel:

Ability to travel as needed (up to 10%) for conferences and corporate and department-wide meetings.

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.