6 results for Regulatory Affairs Executive Jobs in Hanscom Air Force Base, MA, US

Why Sarepta? Why Now?The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene ther...

In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for the Regeneron Cell Medicines, based in Cambridge, MA, a business unit for Regeneron Pharmaceuticals Inc to help advance the use of cellul...

Responsible for regulatory leadership in assigned therapeutic areas, ensuring compliance with global regulatory requirements, directing INDs, NDAs, and BLAs submissions, managing regulatory personnel, and developing regulatory strategies in collaboration with cross-functional teams. Represents the c...

Responsible for leading the regulatory affairs team, developing and implementing regulatory strategies, ensuring compliance with global regulatory requirements, overseeing the preparation of regulatory documents, managing interactions with regulatory agencies, and collaborating with cross-functional...

Responsible for building and overseeing Global Regulatory Science and Regulatory CMC strategies, leading a regulatory affairs team, and ensuring high-quality submissions of INDs, CTAs, and marketing applications. Develops health authority engagement strategies and directs regulatory CMC functions fo...

Responsible for identifying and executing regulatory strategies to support clinical development and commercialization of products. Tasks include preparing regulatory submissions, ensuring compliance with regulations, assisting in regulatory inspections, and maintaining regulatory procedures. Supervi...