- 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
- 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
- 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
- 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
- Ascendis Pharma (Princeton, NJ)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises...Assists in the preparation and revision of company product labeling as appropriate. . Assists in the preparation and… more