- 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
- 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:** 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
- 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
- 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …Global Commercial Insights and Analytics, Market Access and Pricing, Medical Affairs , Health Economics, Regulatory , Data Sciences and Regional Commercial, ... of America **Job Description:** Johnson & Johnson is recruiting for a Senior Director , TECVAYLI(R) & TALVEY(R) Global Commercial Lead located in Raritan, NJ. At… 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
- 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
