- Takeda Pharmaceuticals (Trenton, NJ)
- …seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the ... Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global CMC … more
- Novo Nordisk (Princeton, NJ)
- …+ Train global functions within regulatory affairs as well as global functions within CMC , product supply and device groups in US specific CMC ... Director or Vice President of Regulatory Affairs , the Director of Regulatory Affairs - CMC and Compliance will be responsible preparing CMC … 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
- J&J Family of Companies (Titusville, NJ)
- Principal Scientist, CMC Regulatory Affairs -...to health Authorities. + Contribute to the development of global CMC regulatory strategies and ... Johnson & Johnson is recruiting for a **Principal Scientist, CMC Regulatory Affairs ** to be...product lifecycles, and further ensures that CMC regulatory strategy is in alignment with global … more
- Bristol Myers Squibb (Princeton, 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
- J&J Family of Companies (Titusville, NJ)
- …2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader (1 of 2) located in New ... Director, Global Regulatory Leader (GRL) (1 of...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… 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
- Novo Nordisk (Plainsboro, NJ)
- …VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be ... About the Department Our East Coast Global Development Hub brings together the best minds...Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- Novo Nordisk (Plainsboro, NJ)
- …Director Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... About the Department Our East Coast Global Development Hub brings together the best minds...with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC , Graphics, Legal, Quality, ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...for other regulatory requirements. + Liaise with Regulatory Affairs members and other cross-functional teams… more
- Taiho Oncology (Princeton, NJ)
- …such as clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM or CPIM certification ... (Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary providers etc.) sourcing… more
- Taiho Oncology (Princeton, NJ)
- …(Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary providers etc.) sourcing ... guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are… more