- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Coordinates project activities and needs related to Patient Safety . Ensures compliance with Federal regulations and company SOPs ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/ compliance Updates NAO Patient Safety SOPs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality ... with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in...for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... and under-performing contracts Responsible for staying current on pricing, regulatory guidelines, market trends, and competitive activity, and provides information… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements. Typically has administrative responsibility for recruiting,...as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE). -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... independent audits; manage audit responses and observation resolution. Drive site compliance to regulatory , enterprise, and global requirements through building… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards ... Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines Develops metrics… more
- Henkel (Bridgewater, NJ)
- …CT, United States, Madison Heights, MI, United States, Bridgewater, NJ, Adhesive Technologies ** Product Safety & Regulatory Affairs Specialist** At Henkel, ... in meetings and provides necessary support towards completing the Product Safety and Regulatory Affairs...of Acute and Chronic Health Hazards + Chemical inventory compliance for the US and Canada + OSHA HAZ… more
- Ford Motor Company (Trenton, NJ)
- **Toxicology & Regulatory Compliance Specialist** We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build ... Markets Group (IMG) and China market) and FCSD Managements. Perform various regulatory compliance actions at the federal, state, local, and provincial… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …years regulatory and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU ... life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more
- Ascendis Pharma (Princeton, NJ)
- …global strategies and local regulations . Coordinate US labeling activities for regulatory submissions, product maintenance and safety variations, including ... The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating… more
- Bausch Health (Bridgewater, NJ)
- …prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides ... to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies....regulatory affairs + Working knowledge of the Rx product NDA and labeling processes + Previous course training… more
- Catalent Pharma Solutions (Somerset, NJ)
- …**Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... ** Regulatory Affairs Project Manager** **Position Summary** Catalent Pharma...for the finances of the assigned projects. Prepare annual product reports and ensure on time closure + Facilitate… more
- dsm-firmenich (Princeton, NJ)
- …and hair care actives and personal care specialty chemicals products are evaluated for safety and regulatory conformance + Support the joint efforts of the ... Canada and USA, sunscreen drug listing at FDA and compliance with Proposition 65 and USP. + Work across...team. + Contribute to the development of the NA regulatory strategy for new product innovations which… more
- dsm-firmenich (Princeton, NJ)
- …exceptional customer service on projects, programs and/or processes to ensure regulatory compliance . Monitor and interpret food legislation, ensuring products ... are not limited to, the following: + Accountable for regulatory compliance for existing and new raw...+ Provide customers and business partners with answers for product labelling and compliance -related questions as well… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
