- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready ... critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the… 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
- 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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …for new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local … more
- 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
- 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
- Bristol Myers Squibb (Madison, 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
- J&J Family of Companies (Raritan, NJ)
- …Raritan, New Jersey, United States of America **Job Description:** ** Director , Global Compound Market Access Leader, Neuroscience (2 positions)** **About ... at https://www.jnj.com/innovative-medicine **We are searching for the best talent for Director , Global Compound Market Access Leader, Neuroscience (2 positions), to… more
- Bristol Myers Squibb (Princeton, NJ)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... level strategy for both internal and external opportunities. + Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical Neuropsychiatry position works in the US Medical ... across US functional and commercialization areas to ensure alignment. The Associate Director will report to the Senior Director , US Medical Neuropsychiatry.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and work closely with key members of internal departments including, Legal, Regulatory Affairs , Marketing, Global Health Economics, Value and Outcomes (Global ... training materials. This review is done in collaboration with Legal and Regulatory members (PARC, Promotional Advertising Review Committee) to ensure that all… more
- Ascendis Pharma (Princeton, NJ)
- … labeling , investigator brochures, protocols, informed consent forms, and regulatory submissions + Collaborate with internal and external stakeholders on ... role The role of Program Safety Lead is a director level position here at Ascendis and this Lead...pharmacovigilance agreements, audits, and regulatory inspections + Monitor industry best practices and evolving… more