- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA preferred Travel:Ability to ... capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this ... collection and analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and Regulatory Location - Remote,… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical Affairs , Marketing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Merck & Co. (Rahway, NJ)
- …processes.- Close partnership with colleagues from Sterile Product Development, Quality, Regulatory Affairs , Engineering, and Analytical will be required to ... pipeline.- The FLEx Sterile Process Engineer at the Associate Director level serves as a technical subject matter expert...role model for the culture of perpetual adherence to safety and compliance standards. A successful candidate should have… more
- Merck & Co. (Rahway, NJ)
- …Close partnership with colleagues from Formulation Sciences, Device Development, Quality, Regulatory Affairs , Engineering, and Analytical will be required to ... Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have...based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and Operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas during their rotations. Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, ... Essential Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc. This structured… more
- AbbVie (Irvine, CA)
- …objectives, both strategic and applicable regulatory requirements. Director , Safety , Regulatory and Medical Affairs Quality Standards is responsible ... for the management of a RDQA global Safety , Regulatory Affairs (RA) and...role reports to the Senior Director of Safety , Vigilance and Medical Affairs Quality Assurance.… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs -...**Overview** **THE ROLE:** Reporting to the VP of Global Regulatory & Post-market Safety Affairs , this ... implementation of strategy for multiple complex projects led by the corporate regulatory affairs team, including process improvement for efficiency gain,… more
- J&J Family of Companies (Plymouth, MN)
- Associate Director , Regulatory Affairs - 2406217663W **Description** **Johnson & Johnson** is currently seeking an **Associate Director , Regulatory ... understanding of the Medical Device industry. * Extensive training and education in Regulatory Affairs as related to worldwide product approvals. * A minimum… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... safety issues and product-associated events are reported to regulatory agencies. + Provide regulatory input for...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... regulatory team's engagement in evaluation of risk and safety issues for complex and/or critical products and recommends...Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction… 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 ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Medical Device… more
