- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- Parexel (Raleigh, NC)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, dedicated ... regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting..., Project Management). + 3+ years proven experience in regulatory affairs , particularly in CMC … 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
- Parexel (Raleigh, NC)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… 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
- 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