- 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years… more
- Merck & Co. (Rahway, NJ)
- …closely with other analytical groups in ARD , Global Quality and Regulatory Affairs - CMC to ensure that validated methods are appropriately transferred ... issue management and mitigation plan developmentSupport subject matter experts and regulatory colleagues in authoring of relevant regulatory submission… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Merck & Co. (Rahway, NJ)
- …and must be able to work with all levels of management within and outside of- Global Regulatory Affairs and Clinical Safety (GRACS).Interact closely with the ... to timelines and in agreement with PV local and global regulations.The incumbent must be knowledgeable of global regulatory requirements at a general level… more
- Merck & Co. (Rahway, NJ)
- …Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical ... and investigation/CAPAs . Author and review technical documentation including regulatory submissions. - Advance strategic initiatives across matrixed teams.- -… more
- Merck & Co. (Rahway, NJ)
- …Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, ... reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature… more
- Sanofi Group (Bridgewater, NJ)
- … Regulatory CMC strategies for development and marketed products within Global Regulatory Affairs . You'll have direct contact/liaison with FDA/EMA for ... **Job title:** Manager, Regulatory Affairs CMC -...**Job title:** Manager, Regulatory Affairs CMC - Vaccine + Location:... paradigm shifts that impact the company + Develop Global regulatory CMC strategies and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders ... Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC ...aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC /CP prduct development ... preparation of challenging communications + Manage the preparation for interaction with global regulatory authorities (eg, meetings, IR responses, inspections) +… more
- Sanofi Group (Bridgewater, NJ)
- …partner of Manufacturing & Supply and CMC R&D, collaborating closely with other Global Regulatory Affairs (GRA) and local regulatory functions, and ... Device department, the GRA- CMC Small Molecules Team manages the global regulatory CMC strategy of sanofi's synthetic drugs portfolio (development… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with… more
- Merck (Rahway, NJ)
- …closely with other analytical groups in ARD , Global Quality and Regulatory Affairs - CMC to ensure that validated methods are appropriately transferred ... mitigation plan development + Support subject matter experts and regulatory colleagues in authoring of relevant regulatory ...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Organon & Co. (Jersey City, NJ)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse ... Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal...strategy, Agency Background Packages, participating in Agency meetings on CMC topics, and executing global initial marketing… more
- Organon & Co. (Jersey City, NJ)
- …Primary responsibilities include, but are not limited to: **Responsibilities** Regulatory CMC : + Provide input to global product and project regulatory ... strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the development plans to support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external ... Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Sanofi Group (Bridgewater, NJ)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage development of multiple modalities; experience within regulatory CMC not directly applicable + Demonstrated… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to internal/external stakeholders as applicable. + Regularly review and assess incoming regulatory information in global regulatory intelligence database, ... have:** + Minimum Bachelor's Degree. Advanced life science degree or certification in Regulatory Affairs Sciences preferred. + Minimum of 5 years' experience in… more
- Bristol Myers Squibb (Madison, NJ)
- …Field Medical + Clinical Research and Development + Statistics + Translational Research + Regulatory Affairs including CMC - Regulatory + Manufacturing and ... and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs , Managed Care, Pharmacovigilance, Market Access, Statistics,… more
