Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)
Nurix•Brisbane, CA
•$187,800 - $208,600•Onsite
About The Position
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.
Requirements
- Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or a related life sciences field is required
- Minimum 6+ years in regulatory affairs with a substantial focus on CMC, and 10+ years of overall pharmaceutical/biotech industry experience
- Demonstrated experience authoring and/or compiling CMC (Module 3) content for regulatory submissions for small molecule products
- Working knowledge of ICH quality guidelines and of FDA and/or EMA CMC requirements
- Solid understanding of pharmaceutical development, manufacturing processes, and analytical methods for small molecules
- Strong written communication and scientific/technical writing skills
- Ability to manage multiple projects and competing timelines with attention to detail
- Effective cross-functional collaboration and stakeholder management
- Comfort operating with autonomy while escalating appropriately
Nice To Haves
- An advanced degree (M.S., Ph.D., or Pharm.D.) is preferred
- Familiarity with other global regions is a plus
Responsibilities
- 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, 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
- Ensure submission content is accurate, consistent, scientifically sound, and compliant with ICH guidelines and regional requirements (FDA, EMA, and other markets relevant to the portfolio)
- Contribute to regulatory intelligence by monitoring evolving guidance and precedent and translating it into practical advice
- Oversee quality assurance processes to ensure compliance with regulatory standards, and participate in cross-functional initiatives that improve regulatory submission processes and systems
- At the Associate Director level, take greater strategic ownership and, where applicable, provide line management or mentoring of junior regulatory staff
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What This Job Offers
Job Type
Full-time
Career Level
Senior
