- Sumitomo Pharma (Trenton, NJ)
- …FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory… more
- Organon & Co. (Jersey City, NJ)
- …Primary responsibilities include, but are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and be accountable for the ... Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and implementing… more
- Sanofi Group (Morristown, NJ)
- …with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence ... **Job Title:** GRA Device Lead (Associate Director ) - Digital Health **Location:** Cambridge, MA/ Morristown,...review and approve design control deliverables. + Contribute to product development and lifecycle management planning. Provide… more
- Organon & Co. (Jersey City, NJ)
- …, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to ... oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development .… more
- Organon & Co. (Jersey City, NJ)
- …in written format. + Track record of effective functional representation on product development teams. + Excellent verbal and written communication skills. ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Bristol Myers Squibb (Princeton, NJ)
- …to guide CMC and GPS on trade packaging and commercial product . **Leadership and Matrix Alignment** + **Inclusively Collaborates Across the BMS Matrix with ... + Working knowledge of all functional areas of exploratory development , including chemistry/biochemistry, biology, toxicology, CMC , translational medicine,… more
- Organon & Co. (Jersey City, NJ)
- …guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation ... knowledge-sharing events. + Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa Date: Dec 1, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 63901 **Who we ... are maintained in accordance with established requirements. Lead the development , standardization, implementation, monitor effectiveness and continuous improvement of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, supply chain, and business development ... chain activities in preparation, commercialization, and launch of new products in development in North American market (US and Canada) related to planning,… more