- 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
- Merck (Rahway, NJ)
- …/ Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within ... + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… 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
- 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
- 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