Associate Director, Global Regulatory Sciences - CMC

Role: Associate Director of Global Regulatory Sciences (GRS-CMC) focusing on regulatory CMC strategies for biopharmaceutical products, including biologics, small molecules, and cell therapies, across all lifecycle stages. Responsibilities: develop and maintain global CMC regulatory content for submissions (e.g., INDs, marketing applications, post-approval reports), serve as primary interface between GRS and product development teams, lead assessments of manufacturing change controls, and provide strategic guidance on global regulatory requirements. Manage complex projects, interface with health authorities, and ensure compliance with global regulations.Qualifications: BA/BS with 8+ years in pharma, emphasizing CMC regulatory strategy, regulatory expertise in biologics, small molecules, and cell therapies, and experience with development and post-approval processes. Prefer candidates with knowledge of advanced therapies, analytical methods, and cross-functional leadership skills.HighValue: biologics, cell therapies, small molecules, development and post-approval phases, global regulatory submissions, manufacturing change management, and health authority interactions. WorkSetup: primarily on-site with up to 5% travel.