- 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
- Merck & Co. (Rahway, NJ)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … 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
- Coty (Morris Plains, NJ)
- Senior Manager, US Regulatory Affairs and...policy development and defense. This position reports to the Director , NA Regulatory Affairs and ... Ingredient Support **SENIOR MANAGER, US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking for smart leaders who are fast and passionate!** **We… 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 ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… 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)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... medicine.Summary, Focus and Purpose:The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning and directing clinical research… 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)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… 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
- 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
- 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
- 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
- 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 , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready to ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs ( US RA AdPromo)...different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Regulatory Affairs (RA) Business Operations believe talented people deserve ... to the terms and conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed to providing equal employment… more
