Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides

Role: Provide strategic, tactical, and operational regulatory CMC leadership for advanced therapeutic modalities, focusing on synthetic peptides and oligonucleotides to support clinical development, market registration, and post-approval activities. Responsibilities: Develop and implement regulatory strategies, review and prepare CMC documentation for global submissions, and guide cross-functional teams on development and lifecycle management, considering unique aspects like impurity profiles, stability, and delivery systems. Requirements: B.S. in a science, engineering, or related field; 10+ years in Regulatory CMC supporting complex modalities, preferably with experience in peptides/oligonucleotides. Skills: Deep technical knowledge in CMC development and manufacturing sciences, global regulatory requirements, and experience authoring regulatory content. Preferred: Experience with global submissions, regulatory interactions, and complex modality development considerations. HighValue: expertise in synthetic peptides and oligonucleotides, global CMC regulations, clinical and commercialization support, lifecycle management, and cross-functional collaboration at senior levels. WorkSetup: Not specified.