- 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 ... affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Merck (Raleigh, NC)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... in business process mapping, gap analysis, and workflow optimization for CMC / regulatory authoring. + Practical knowledge of content models/structured content,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… 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. ... solutions + 4+ years of experience with Life Sciences Pharmaceutical R&D regulatory data lifecycle . Experience to include introducing new technologies like GenAI,… 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
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role… 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
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... engages as appropriate in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing expertise and perspective… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... engages as appropriate in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing expertise and perspective… more