Director/Senior Director, Regulatory Affairs, CMC

Role: Lead global Regulatory Affairs CMC team for biologics and small molecules, supporting registration strategies to achieve product approvals in US, EU, and other markets. Responsibilities: develop and execute CMC regulatory strategies, manage dossier content for INDs, BLAs, and MAAs, evaluate manufacturing change impacts, lead agency interactions, ensure compliance of electronic submissions, and provide strategic counsel across development stages. Collaborate with China development teams and external CROs/CDMOs to facilitate smooth regulatory processes. Qualifications: BS in a scientific discipline with 10+ years in pharma/biotech and at least 6 years in CMC regulatory roles; advanced degrees (PhD, PharmD) preferred. Proven track record with US/EU CMC submissions, IND and NDA/BLA approvals, and agency interactions. High-value specifics include expertise in biologics and chemical drug development, GMP, ICH guidelines, and familiarity with eCTD and related infrastructure. Experience with post-approval, ADCs, or antibody projects is a plus. Skills: scientific and manufacturing acumen, leadership, problem-solving, and excellent communication. Knowledge of global regulatory landscapes, including EU requirements, is desirable. Work setup details are not specified.