Associate Director, CMC Regulatory Affairs

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Not verified last checked Jun 13, 2026

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401(k) match

Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

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About this role

Associate Director, CMC Regulatory Affairs Waltham, MA, United States Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory direction and managing CMC related activities in close partnership with cross-functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals. This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work. Key Responsibilities: Lead regulatory CMC strategy and execution for assigned development programs. Provide regulatory and scientific expertise to shape CMC strategies for development programs. Collaborate cross-functionally with technical and regulatory teams to support product development and lifecycle management. Oversee preparation, review and submission of high-quality CMC sections for investigational and registration submission (INDs, IMPDs, NDAs, MAAs and amendments) in alignment with Health Authority requirements. Work within the department and cross-functionally to establish regulatory CMC strategies for product development and commercialization. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Lead teams in preparation of responses to Health authority

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