- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... of PV agreements, PV plans, and SMPs.Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal guidelines… more
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences ... areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process and analytical development, technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics and ... our program partner Janssen. This effort will extend to joint technical and CMC committees that report to the Joint Manufacturing Committee in the commercial… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Information to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Organon & Co. (Jersey City, NJ)
- …Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Merck (Rahway, NJ)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... end-to-end scope includes Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to ongoing business process… more
- Merck (Rahway, NJ)
- **Job Description** Under minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... PV agreements, PV plans, and SMPs. + Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal guidelines… more
- Merck (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
