Associate Director, Regulatory CMC

Role: Associate Director, Regulatory CMC, leading global regulatory activities for investigational and commercial small molecule and antisense oligonucleotide (ASO) products. Responsibilities: develop and execute CMC regulatory strategies; author and review CMC content for submissions such as INDs, IMPDs, NDAs, BLAs; coordinate with cross-functional teams (Quality, Analytical, Development, Manufacturing); support health authority interactions and lifecycle management activities including post-approval changes and technology transfers; oversee external vendors and consultants. Requirements: Bachelor's, Master's, or Ph.D. in a relevant science discipline; 10+ years in Regulatory CMC or technical CMC roles, with hands-on experience managing CMC content for regulatory submissions, particularly for small molecules and preferably for ASOs; deep technical expertise in formulation, analytical development, manufacturing, or related fields; strong knowledge of FDA and global CMC requirements; demonstrated leadership in complex CMC projects and external interactions; proficiency with digital tools and AI in document/data management; excellent project management and communication skills. HighValue: global regulatory strategy, CMC technical expertise, experience with small molecules and oligonucleotide therapies, regulatory submissions at IND and NDA stages, lifecycle and change management, interaction with manufacturing and quality teams. WorkSetup: remote with flexibility and travel as needed.