- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …emerging genetic medicine modalities in collaboration with the PK Subject Matter experts, Regulatory Affairs , and other relevant stakeholders. + Manage team of ... Regeneron is seeking a highly motivated ** Manager , Scientific Writing** to supervise regulatory ...Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content. **A Typical Day Looks… more
