Description
The Director, Regulatory Affairs with CMC focus manages regulatory CMC activities for Miltenyi Biomedicine’s cell therapy programs across the United States, Canada, and other regions. The role develops CMC regulatory strategies, leads IND, CTA, BLA, and MAA CMC preparation and health authority interactions, supports manufacturing and change-control activities, and identifies regulatory risks. It requires a bachelor’s degree in life sciences, at least 15 years of biotech or pharmaceutical experience, extensive GMP and CMC regulatory knowledge, and mandatory cell and gene therapy CMC, late-stage development, and commercial launch experience. The position offers a salary range of $201,579 to $237,206 per year, with health, vision, dental insurance, and a 401(k) plan.
