- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio… 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 ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- J&J Family of Companies (Raritan, NJ)
- Sr. Director Medical Affairs TA Leader XTA - 2406217684W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare ... + Accountable for the delivery of the TA portfolio and ensures risk ( regulatory , CMC and/or clinical) mitigation/escalation and mitigation of critical issues… more
- Merck (Trenton, NJ)
- …pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... + Lead quality oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation and submission of… more
- J&J Family of Companies (Titusville, NJ)
- …- 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey ... and ensures strategy is in alignment with regional teams, CMC , commercial strategies, and the Target Product Profile +...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- Merck (Trenton, NJ)
- …Description of Position-** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... standards. + Provide strategic advice to senior management on CMC regulatory matters based on health authority...analysis of data for management review. **Reports to** - Director Regulatory Compliance, Device Quality and … more
- Novo Nordisk (Plainsboro, NJ)
- …Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... to make a difference? The Position The International Medical Director serves as a subject matter expert for our...with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- WuXi AppTec (Plainsboro, NJ)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… 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 ... Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA...CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary… more
- Cardinal Health (Trenton, NJ)
- …+ Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls ( CMC ) Development + Nonclinical Development ... selling to Pharmaceutical, Biotech and Medical Device companies client preferred. + Regulatory affairs , drug development understanding is highly preferred. +… more