Executive Director, CMC Regulatory Science

Role: Lead and oversee the development and implementation of CMC regulatory strategies for multiple biopharma products, ensuring regulatory compliance and facilitating agency interactions. Responsibilities: manage a team of CMC experts, prepare high-quality regulatory submissions (IND/CTA/BLA/MAA), review documents, lead discussions with health authorities, develop processes and templates, and interpret domestic and international regulations across therapeutic areas including vaccines, oncology, and rare diseases. Requirements: MS/PhD in a scientific or engineering discipline; 10+ years in pharma/biotech with 8+ years focused on Regulatory CMC, including DMF/ASMF submissions; strong knowledge of US, EU, ROW regulations, CTD formatting, and excellent communication skills. Preferred: advanced degree in Molecular Biology, Pharmaceutics, or Chemistry; additional experience in biologics, manufacturing, or analytical areas. High-Value: biologics, vaccines, oncology, rare diseases; CMC strategy development, agency interactions, regulatory documentation, and oversight of multiple programs. WorkSetup: based at Norwood MA, with a focus on regulatory leadership and cross-functional collaboration.