- J&J Family of Companies (Raritan, NJ)
- Associate Director , CMC Regulatory Affairs + Job titleAssociate Director , CMC Regulatory Affairs + FunctionDiscovery & ... Share **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs . This position can be… more
- 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product… more
- Organon & Co. (Jersey City, NJ)
- …the Associate Principal Scientist (Associate Director ) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase ... **Job Description** **The Position** Reporting to the Director in Organon Regulatory Chemistry, Manufacturing...colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… 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
- Organon & Co. (Jersey City, NJ)
- …for the preparation and review of information required for development of regulatory CMC dossiers for commercial products including original registrations, ... **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and...communicate potential regulatory issues to our company's Regulatory CMC management, as needed. **Required Education,… more
- Merck (Rahway, 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the… more
- WuXi AppTec (Cranbury, 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
- Novo Nordisk (Plainsboro, NJ)
- …VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be ... to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be...Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more