- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… 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)
- …focus even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory , quality assurance and other requirements when ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... collaboration with key global stakeholders Help to ensure a high state of compliance to company policies and procedures within the global GSO organization Assist… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director ... from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital...and standardizing data, with a focus on eg, clinical, product , and vendor data and Identify and rectify data… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functional groups to enable robust production, testing and release of product to patients. Key Responsibilities Assisting in Scheduling, planning, and organizing ... of Work orders and vendor documents to ensure GXP and quality compliance . Maintain vendor training records, schedule vendor trainings. Maintain facility cleaners… more
- Sun Pharma (Taro Pharma) (New Brunswick, NJ)
- …risk assessment and risk management fundamentals/tools.Strong knowledge of cGMP, QA/QC and regulatory compliance (US, EU and other regulatory ... Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely… more
- Burlington (Burlington, NJ)
- **LOCATION** 1830 Route 130 North Burlington NJ US 08016 **Overview** The ** Product Safety & Regulatory Compliance Manager** will play an integral role ... in supporting Burlington's Product Safety & Regulatory Compliance Center of Excellence. The Manager will engage with cross-functional partners, third… 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 ... for the development and implementation of labeling content and strategy of assigned product (s) in various stages of drug development, which may include products of… more
- Bausch Health (Bridgewater, NJ)
- …to enhance efficiencies and compliance . + Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents ... committees for prescription products to review promotional materials to ensure compliance with regulatory requirements while meeting the Company's strategic… 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
