- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... registration and life cycle support and the leadership of regulatory strategy for projects that are currently US...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... **Job Description** **The Position** The Principal Scientist ( Director ) Regulatory Chemistry, Manufacturing and Controls...A better and healthier every day for every woman. ** US and PR Residents Only** For more information about… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Eisai, Inc (Nutley, NJ)
- …that drives optimal access and utilization of Eisai marketed products in the United States .Provide input to the health economics and outcomes research ... your profile, we want to hear from you. The Director , US HEOR and RWE (field) is...the employment eligibility of all new hires in the United States . Please click on the following… more
- Merck & Co. (Rahway, NJ)
- …responsibilities.Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains, with an ability to ... or equivalent regulatory authoring/publishing platforms.Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing,… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... cross-functional development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of the Pneumococcal Vaccines Executive Director , Value & Implementation (V&I) Outcomes Research, the incumbent has the primary ... Business Lines strategies and direct market responsibilities in the US aligned with the US Market strategy.-...ensure that product value is defined and developed. The Director also works closely with Product Development Teams, Franchise… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of an Executive Director , within the Value & Implementation (V&I) Outcomes Research team the incumbent has the following ... Teams, Franchise Teams, Regional Product Directors, our company's affiliates, Public Affairs , and Medical Education to ensure value evidence programs are consistent… 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 ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global ... Medical and Scientific Affairs as well as Outcomes Research.Under the guidance of...development of American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers for use by… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department:...as one of the leading generic organizations in the United States . Today we have a diverse ... ANDA products. The incumbent might also be designated as US Agent (back-up) for the US Office...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as the ... or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs...different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs , Advertising and Promotion Director . The Manager ... be for you if you can/Have** + Management of US regulatory activities associated with advertising and... advertising and promotion perspective with guidance from the Regulatory Affairs , Advertising & Promotion Director… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy ... in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST).… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and… more
