- Amneal Pharmaceuticals (Piscataway, NJ)
- …and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal ... a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs… more
- Cardinal Health (Trenton, NJ)
- …hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory/ compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong ... + Handle fast paced and high-volume workload + Identify legal and compliance issues and business risks and escalate appropriately + Effectively communicate with… more
- Merck (Trenton, NJ)
- …Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical Regulatory ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary… more
- Integra LifeSciences (Princeton, NJ)
- …quality systems, and a commitment to ensuring product safety and compliance . The ideal candidate should demonstrate proficient experience with quality management ... improvement **SUPERVISION RECEIVED** Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls. **SUPERVISION EXERCISED** Indirect supervision of… more
- Sysco (Rahway, NJ)
- …System (QMS) that ensures product excellence, customer satisfaction, regulatory compliance , and business continuity across the entire supply chain-from development ... assurance and control programs-including product specifications, testing protocols, and compliance frameworks for both in-house and third-party operations. + Lead… more
- Sumitomo Pharma (Trenton, NJ)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... preferred. + Minimum 3 years' experience within Pharmacovigilance and in the pharmaceutical industry. + Prior experience in oncology, and/or neurology is strongly… more
- Teva Pharmaceuticals (Edison, NJ)
- …and participate in factory acceptance testing and commissioning support, ensuring compliance with company and regulatory standards. + Collaborate with Engineering, ... for Engineering Studies to establish robust equipment operating parameters. + Ensure compliance with the Site Validation Master Plan and Validation Project Plans,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …products using USP/NF, EP, in-house test methods and standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal ... is an entry level, and it contributes to tasks associated to pharmaceutical analysis intended for drug product development. The preliminary activities include… more
- System One (Florham Park, NJ)
- …in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare ... and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This includes publishing...Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and… more
- Hovione (East Windsor, NJ)
- …as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people ... equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes… more