- Merck (Raleigh, NC)
- …project management activities to ensure efficient execution and compliance within CMC operations. The responsibilities of the dCMC Business Analyst include: Business ... Process Mapping and Optimization : Working with Digital CMC and associated business stakeholders, the analyst will map end-to-end processes that produce regulatory… more
- Parexel (Raleigh, NC)
- …options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager ** to join a growing, dedicated client partnership ... department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Merck (Raleigh, NC)
- …project management activities to ensure efficient execution and compliance within CMC operations. **The responsibilities of the dCMC Business Analyst include:** + ... **Business Process Mapping and Optimization** : Working with Digital CMC and associated business stakeholders, the analyst will map end-to-end processes that produce… more
- ThermoFisher Scientific (Wilmington, NC)
- …to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical operational and ... may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; eg process… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Deloitte (Charlotte, NC)
- …Recruiting for this role ends on 12/20/2025 Work you'll do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... and generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Experience with cloud computing… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- ThermoFisher Scientific (Greenville, NC)
- …engages as appropriate in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing expertise and perspective ... understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + Advanced understanding of medical terminology, statistical… more
- ThermoFisher Scientific (Greenville, NC)
- …engages as appropriate in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing expertise and perspective ... understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + Advanced understanding of medical terminology, statistical… more
