- Merck & Co. (North Wales, PA)
- …to relevance, importance, time sensitivity, and impact which is critical to maintaining regulatory compliance . This team also monitors a list of relevant ... curious, join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across the… more
- Merck & Co. (Rahway, NJ)
- …an effective implementation and oversight model to maintain best-in-industry regulatory compliance .The Vice President Regulatory Affairs, ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Eisai, Inc (Nutley, NJ)
- …educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new ... crisis management.Manage IT training programs and conduct Segregation of Duties reviews. Regulatory Compliance Activities:Collaborate with legal and compliance… 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …support system and/or process enhancements to support business needs and/or regulatory updatesSupport additional compliance initiatives and projectsFoster a ... maybe you will be our next Manager of US Compliance ! This role will implement day-to-day support across the...This role will implement day-to-day support across the US Compliance Business Partner team to provide relevant guidance 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
- 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
- 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
- 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …brand's HCP Agency of Record.Work closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly ... business partner to manage spend to budget.Ensure culture of compliance .Qualifications:Bachelor's degree required; MBA preferred.Requires a minimum of 5-10 years… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …requirements Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards. Work ... documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements Participate as an CSV SME in audits and inspections… more
- Aequor (Thousand Oaks, CA)
- …support of product development? Knowledge of protein and small molecule quality, compliance and regulatory requirements? Knowledge of analytical techniques used ... executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory , Process Development, Quality Assurance, and other functional areas… more
- Insmed Incorporated (Bridgewater, NJ)
- …are conducted on assigned complaints to ensure completeness, accuracy, and regulatory compliance , including batch reviews, identify root causes, replacement ... Product Quality Complaints. The primary responsibilities include managing QA Compliance activities, including technical writing of Deviations/CAPA/EC documents. Monthly/Quarterly… more
- Novo Nordisk Inc. (New York, NY)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
