- United Therapeutics (Research Triangle Park, NC)
- …the back of your hand - you might be exactly who we're looking for. The Regulatory Affairs Manager will manage and lead the preparation, compilation, and ... for assigned projects. This role will collaborate with the manager , project teams, and functional area representatives to devise...discipline + 8+ years of direct experience with a regulatory affairs CMC role with… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more