About this role
Associate Director, Regulatory CMC at Summit Therapeutics. Location: Palo Alto or Princeton or Miami. Role: planning submissions, coordinating reviews, managing timelines Requirements: Bachelor’s degree in chemistry, pharmacy, engineering, or biochemistry; 6+ years Regulatory CMC experience; experience with biologics; strong FDA/EU regulatory knowledge; experience preparing CMC submissions (IND/IMPD/BLA/MAA). Mandarin desirable. Category: Legal and Compliance Seniority: Senior Level Tools: Microsoft Word, Microsoft Excel, Document management systems Commitment: Full Time Workplace: Hybrid Languages: English