- EY (Detroit, MI)
- …better working world for all.Financial Services Risk Management Advisor, FSRM ( Regulatory Compliance /Consumer) - Financial Services Office (Manager) (Multiple ... MI. Provide clients with strategic recommendations to identify, measure and manage regulatory compliance issues. Help clients to meet their regulatory… more
- BioAgilytix (Durham, NC)
- …in the update, enhancement, and creation of internal policies and proceduresSupports regulatory compliance to ISO, FDA, and other worldwide regulatory ... supplemental submission)Advise on impact of regulations, devises strategies for compliance and acts as liaison with regulatory ...for compliance and acts as liaison with regulatory bodies and sponsors for facility inspections, licensure and… more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... to the world.Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... 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)
- …to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… 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 ... SOPs/Forms, Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory , and customer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …critical role in partnering with other NNI teams to drive health systems strategy Regulatory and Compliance Alignment: Ensure that all aspects of the diagnostic ... and precision health strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Will utilize prior academic experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding ... Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the USDA, FDA, CDC, and other similar… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customer service. Essential Functions Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific ... Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Trinity Health (Columbus, OH)
- …and documents results of activities performed to comply with all regulatory and standard requirements.Notifies equipment users, CE Managers, and Regional Director ... of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific guidelines ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Aequor (San Diego, CA)
- …queries and contribute to specified PV sections. Ensure pharmacovigilance regulatory compliance with oversight, as needed.Position ResponsibilitiesParticipate in ... strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary /… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … task forces, who's goal is to assess impact and oversee the company's compliance with new and changed regulatory obligations related to Corporate Compliance ... is required. A minimum of 10+ years combined pharmaceutical, legal, regulatory , and compliance experience required Or a minimum of 8 years experience if… more
- Catalent (Philadelphia, PA)
- …patient and employee safety, will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer ... metrics, batch records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory , & customer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon ... approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements...files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP guidelines Provides support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market dynamics, especially within specified therapy area preferredStrong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
