Associate Director, Regulatory Affairs - CMC

The Associate Director of Regulatory Affairs – CMC at PTC Therapeutics leads global regulatory strategies for small molecule product development, registration, and post-approval lifecycle management. This role oversees the preparation of high-quality CMC dossiers, manages interactions with regulatory agencies, and ensures adherence to international guidelines like ICH standards. The position involves collaborating cross-functionally with Technical Operations, Quality, and Regulatory teams to drive successful submissions and approvals.