- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: The Senior Manager , Corporate Counsel will be an integral member of the Amneal Legal team and will serve as a trusted legal advisor for all commercial ... payers,etc.) to ensure that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies. + Counsel on… more
- Abbott (Newark, NJ)
- …product developments * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, ... PURPOSE OF ROLE** As a member of the regional sales team, the Territory Manager II will be responsible leading the strategy within an assigned territory to… more
- System One (East Windsor, NJ)
- …as and when needed. + This position will also review all finished product batches for compliance with applicable regulatory requirements and current Good ... FDA of illegitimate products. + Assist the Associate Manager of QA Compliance in notifying the FDA...+ As needed, conduct social media monitoring for any product quality or safety-related complaints and inform the third-party… more
- Bristol Myers Squibb (Princeton, NJ)
- …regulatory experience in GxP environment. + Previous proven experience dealing with FDA and other major regulatory agencies. + Experience with digital ... (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle-from R&D to commercialization. Responsibilities include leading Quality… more
- Atlantic Health System (Summit, NJ)
- …to purchase supplies in a cost-effective manner. + Evaluates new instrumentation/equipment/ product purchases as directed by the Site Manager . Communications: ... compliance. + Provides remediation as indicated. + Participates in in-services as required. Regulatory Compliance (CAP, CLIA, JCAHO, FDA ): + Updates and monitors… more
- Integra LifeSciences (Princeton, NJ)
- …processes in the company, addressing endotoxin-related risks from both a product and patient safety perspective. ** Regulatory Compliance & Documentation:** ... understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The candidate must be a senior-level professional/team… more
- Sanofi Group (Morristown, NJ)
- …part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from ... the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver...plans (IDP) + Contribute in the definition of the product value proposition (TVP), Target Product Profile… more
- Sanofi Group (Morristown, NJ)
- …+ Contribute to the clinical part of Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc.) and answer to questions from health ... the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver...action plans + Contribute in the definition of the product value proposition (TVP), Target Product Profile… more
- ConvaTec (NJ)
- …Under Bond (TIB) process for goods entering the country for temporary purposes ensuring regulatory adherence. + Manage the FDA Import for Export (IFE) program ... and Trade Compliance Specialist will help support the Customs and Trade Compliance Manager with operational guidance and support of Convatec locations in the US, CA… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more