- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to...tasks and assignments Participates in department forum meetings eg CMC , PRB, and ensures that proper minutes from these… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to ... Support CMC development activities from a regulatory standpoint during early phase, development, submissions and post market requirements for gene therapies. **A… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry… more
- Novo Nordisk (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... to compose letters incorporating NN position on external regulatory initiatives + Works with Group Manager ...and assignments + Participates in department forum meetings eg CMC , PRB, and ensures that proper minutes from these… more
- System One (Florham Park, NJ)
- …+ Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance in a ... meetings to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across regulatory… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …including, but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA), Regulatory Affairs and ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
