- Parexel (Trenton, NJ)
- …innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, ... requirements. Project Management: Serve as the project manager for meetings, adhering to best...Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing,… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs ... Nonclinical, CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor new regulations and guidelines to ensure internal processes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in ... Raritan, NJ.Role OverviewThe MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead… more
- Givaudan Fragrances (East Hanover, NJ)
- …by engaging with partners across regions and departments. Represent us with regulatory authorities and industry associations on CMC matters. Advise management ... the development of global policies, processes and systems to ensure regulatory chemical compliance. You'll build cross functional collaboration with Commercial,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … 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...Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
