Associate Director, Regulatory Affairs - CMC

Role: Associate Director, Regulatory Affairs – CMC, leading global regulatory strategy for small molecule drug development and registration. Responsibilities: oversee preparation of CMC documentation for filings such as NDAs, INDs, and MAAs; lead lifecycle management and post-approval change strategies; collaborate cross-functionally with Regulatory Affairs, Technical Operations, and Quality teams; manage agency interactions; ensure compliance with global regulatory guidance and industry standards. Requirements: Bachelor's in a scientific discipline, 7-8+ years’ experience in Regulatory Affairs or CMC technical writing within pharma/biotech; deep knowledge of small molecule development, GMP, ICH regulations, and global regulatory processes; proven experience in preparing submissions and managing lifecycle changes; strong collaboration, communication, and project management skills. Preferred: advanced degree (Masters or PhD), experience in non-ICH regions, and knowledge of regulatory aspects beyond CMC. HighValue: small molecules, global regulatory environment, lifecycle management, IND/CTA/NDA/MAA submissions, up to 20% travel. WorkSetup: remote with up to 20% travel.