- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we ... **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ)...committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without… more
- System One (Florham Park, NJ)
- Senior Manager , Regulatory Affairs Strategy - Contractor Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview ... The Contractor - Senior Manager , Regulatory Affairs - Quality...meetings related to QOL initiatives. + Support coordination with global regulatory counterparts to ensure alignment of… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- …it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading ... Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible for personal care,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of ... regulatory affairs related to the development of...+ Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and… more
- Englewood Lab, Inc (Totowa, NJ)
- Reports to: Manager of Regulatory Affairs Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and ... the Head of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during...elements of ISO 13485:2003. + Maintain familiarity with changing global regulatory requirements. + Ability to work… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- Englewood Lab, Inc (Totowa, NJ)
- …(QMS) in compliance with US 21CFR 210, 211. + Maintain familiarity with changing global regulatory requirements. + Assist with CARES Act drug reporting, Product ... Responsibilities + Assist the Manager during cGMP, Environmental, and Regulatory audits. + Assist the Manager to create and collate product master files… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to ... with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and the tracking… more
- Insight Global (New York, NY)
- Job Description Insight Global is looking for a Senior Regulatory Project Manager to join one of our financial clients in NYC. This individual will be ... be responsible for delivering on complex projects within the Regulatory Affairs Program portfolio. Day to day...Requirements - 10+ years of professional experience as a Regulatory Project Manager within financial services -… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …including but not limited to: Global Patient Safety (GPS), Medical Affairs , Regulatory , Commercial, etc. + Participate in process improvement activities, ... and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. ...global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality… more
- Pfizer (New York, NY)
- …matrix organization and interacts with Epidemiologists, Biostatisticians, Clinical Operations, Global and Regional Medical/Scientific Affairs , Pfizer Research ... **ROLE SUMMARY** The Clinical Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs.… more
- S&P Global (New York, NY)
- …consistency in carrying out compliance responsibilities. + Consult with the Legal & Regulatory Affairs Department, as needed, to resolve complex regulatory ... will be a direct liaison and a point of escalation contact for S&P Global Ratings data and technology activities from a Compliance, Risk & Internal Controls… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC, Graphics, Legal, Quality, Supply ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...for other regulatory requirements. + Liaise with Regulatory Affairs members and other cross-functional teams… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …product development, registration, and post-market support + Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety. ... Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will perform signal management process activities for assigned products,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …regulations and guidelines. + Understanding of ICH guidelines, GVP modules, and other global regulatory requirements. + Familiarity with FDA, Health Canada, and ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines… more
- The Mount Sinai Health System (New York, NY)
- …standards. Works closely with Tisch Cancer Institute offices (ie Quality assurance, regulatory affairs , disease specific clinical trial managers). + In ... **JOB DESCRIPTION** The Program Manager is an integral member of the Tisch...operational, and programmatic intricacies within the Cancer Institute among regulatory affairs , research finance, clinical operations, oversight… more
- Pfizer (New York, NY)
- …implementation of cluster-level strategy in collaboration with the Study Operations Manager / Global Study Manager . Provide regional exploration/territory ... growing adjacent opportunities where possible. Provide support to the Study Operations Manager / Global Study Manager to define local requirements for… more
- Pfizer (Pearl River, NY)
- …and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs ... for managing operational Quality projects with a focus on Clinical Quality Regulatory tasks. There are many compliance tasks that will be driven independently… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in the ... limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts… more