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About the role
Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Report to the Senior Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecules) as a key member of the Regulatory Affairs team
- Develop, communicate, and execute global CMC regulatory strategies for assigned programs (drug substance and drug product) across the product lifecycle
- Assess the regulatory impact of manufacturing, analytical, formulation, and supply chain changes, and recommend filing strategies and categorization (e.g., substantial, non-substantial, annual reportable)
- Provide proactive CMC regulatory guidance and risk assessment to development, technical operations, and commercial teams
- Partner with Technical Operations/Manufacturing, Analytical Development, Quality Control, Quality Assurance, Supply Chain, and CMOs/CDMOs (where applicable) to align technical activities with regulatory requirements
- Represent CMC Regulatory on project and CMC sub-teams, and manage submission timelines and deliverables in coordination with regulatory operations and publishing
More about this role
Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff.
- Report to the Senior Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecules) as a key member of the Regulatory Affairs team
- Develop, communicate, and execute global CMC regulatory strategies for assigned programs (drug substance and drug product) across the product lifecycle
- Author, review, and compile high-quality CMC (Module 3 / Quality) content for regulatory submissions, including IND/IMPD and equivalent global filings, amendments, annual reports, and responses to health authority questions
- Assess the regulatory impact of manufacturing, analytical, formulation, and supply chain changes, and recommend filing strategies and categorization (e.g., substantial, non-substantial, annual reportable)
- Provide proactive CMC regulatory guidance and risk assessment to development, technical operations,...
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