- Canon USA & Affiliates (Trenton, NJ)
- …Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum ... ** Regulatory Affairs Specialist - Post Market...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
- Novo Nordisk (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... About the Department The Clinical, Medical and Regulatory (CMR) department at...relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs , Precision Medicine, you will help develop and execute ... Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx ...on business. + Support training related to the IVD/CDx medical devices & broader Precision Medicine initiatives. + Ensures… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory development and ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver...practice + Exceptional understanding of medical concepts and terminology + Strong written and oral… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Atlantic Health System (Morristown, NJ)
- …ambulance agreements, and home health and hospice agreements, assuring legal and regulatory compliance. Serve as a primary resource for the interpretation of ... on healthcare laws and regulations, including, without limitation, monitoring of regulatory developments, and legal research on regulatory issues, including… more
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