Director, Regulatory CMC Biologics (Cell Therapy) - (Summit, NJ)

Other Locations:US- NJ- Summit WestDescriptionCelgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.Responsibilities include, but are not limited to, the following:Responsible for the development of the CMC regulatory strategy for our cell therapy submissions. These submissions include Health Authority Briefing Packages/IND/IMPD/BLA and MAA regulatory filings. Coordinate the preparation and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions.