- Coty (Morris Plains, NJ)
- …part of the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...retailers. + Provide guidance to Product Development regarding OTC labeling and claims. Including working with the global artwork… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring… more
- J&J Family of Companies (Raritan, NJ)
- …looking for a dynamic and visionary leader to join our Cross-Regional Regulatory Affairs team as ** Director , Labeling Science and Technology Leader** . ... be considered as a single submission. ** Director , Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs ** Are you ready to shape the… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and... impact of new campaign concepts, target, or product labeling , and providing strategic regulatory guidance on… 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 ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... conversion to OTC or OTC Monograph direct including any labeling reviews and updates. + Ensure all manufacturing, packaging,...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… 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 ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… 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...prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy… 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 -...maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates significant autonomy… more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- Sumitomo Pharma (Trenton, NJ)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for… more
- J&J Family of Companies (Raritan, NJ)
- …safety, market access, commercial, medical affairs ) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … 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 ... This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface… more
- Ascendis Pharma (Princeton, NJ)
- …promotional assets for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling , advertising, and ... Global Communications, and other functional group contributors to support the US Medical Director in successful management of Medical Affairs projects. + Support… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs , and Pharmacovigilance. External collaboration includes ... issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA… more
- J&J Family of Companies (Raritan, NJ)
- …matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics, ... adverse events (pre and post-marketing) for relationship to treatment + Assists Regulatory Affairs in determining requirement for any corrective actions or… more
- J&J Family of Companies (Titusville, NJ)
- …interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring & ... of medical publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device regulatory strategies… more
- J&J Family of Companies (Titusville, NJ)
- …for product hierarchies, nomenclature, and lifecycle transitions. + Partner with Regulatory Affairs , Clinical Operations, Supply Chain, and Commercial to ... IM), a pharmaceutical company of Johnson & Johnson is recruiting for a ** Director ,** **R&D Data Science,** **MDM Products** This position has a primary location of… more
- Bristol Myers Squibb (Princeton, NJ)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** The… more
- J&J Family of Companies (Raritan, NJ)
- …products throughout the lifecycle + Connect with respective colleagues in the Clinical TA, Medical Affairs , Global Regulatory Affairs and the QPPV J&J IM for ... America **Job Description:** Johnson & Johnson, is recruiting for a Executive Director , Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ;… more
