Associate Director, Regulatory CMC

Role: Associate Director, Regulatory Affairs, CMC, overseeing global regulatory filings and strategies for biologics in oncology, supporting multiple phase 3 clinical trials in NSCLC and CRC. Responsibilities: develop and finalize CMC regulatory documents, lead regulatory strategy in project teams, coordinate submission preparations (IND, IMPD, BLA), manage interactions with health authorities, review submissions for compliance, and continuously improve processes. Requirements: Bachelor's in Chemistry, Pharmacy, or related field; 6+ years in regulatory CMC within pharma/biotech, with biologics experience; strong knowledge of FDA/EU regulations; proficiency in preparing CMC sections for various submissions; excellent communication and organizational skills. Preferred: Master's or advanced degree; experience in global regulatory environments; fluency in Mandarin highly desirable. High-value: biologic modalities, oncology indications, late-stage clinical development (Phase 3), global regulatory submission expertise, and cross-functional collaboration. Work setup: hybrid, with 4 days on-site at Palo Alto, CA, Princeton, NJ, or Miami, FL; no specified travel.