Senior Manager, Global Regulatory Affairs, CMC

Role: Senior Manager, Regulatory Affairs Global CMC, managing registration and CMC regulatory support for biological products across global markets. Responsibilities: prepare and review Module 2 and 3 CTD sections for submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs), develop regulatory CMC strategies for commercial and development programs, conduct risk assessments, coordinate responses to regulatory agencies, ensure compliance with change control and regulatory information management procedures, maintain product information for clinical and commercial products, and support continuous improvement initiatives. Requirements: BSc/BA with relevant regulatory CMC experience; strong understanding of drug lifecycle regulations, especially for biologics; experience with electronic Common Technical Document (eCTD) submissions; familiarity with FDA, EMA, and ICH guidelines; excellent communication and interpersonal skills. Preferred: knowledge of global regulatory processes and cross-functional collaboration. HighValue: biological products, CMC regulatory submissions, global market support, late-stage development, commercial product maintenance. WorkSetup: not specified; likely hybrid or office-based given regulatory collaboration.