- 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
- 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)
- …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 workPossesses in-depth ... knowledge of regulatory authority's requirementsTypically has administrative responsibility for recruiting, retaining, developing, and managing employeesGuide career… 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
- 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
- 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
- Catalent (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... a Patient First culture through excellence in quality and compliance , and to the safety of every... bodiesAnticipates internal and or external business challenges and/or regulatory Issues; recommends process, product or service… 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
- 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
- Catalent (Philadelphia, PA)
- …and employee safety , will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer ... a Patient First culture through excellence in quality and compliance , and to the safety of every...records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Catalent (Philadelphia, PA)
- …and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. ... that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish… 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
- Chemours (Trenton, NJ)
- …you will contribute to our business success by providing subject matter expertise on product compliance , safety and sustainability. You will be tasked with ... + Bachelor's degree with 5+ years work experience + Previous product stewardship or regulatory compliance experience + Excellent analytical skills +… 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
