- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company ... portfolio of clinical trials.- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The… more
- Formation Bio (New York, NY)
- …on-board products with strong IP potential, and thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person ... of use patents, lifecycle management strategies, process-related discoveries and labeling -related IP issues Oversee trademark, trade secret, and data exclusivity… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... from concept to implementation, ensuring that our packaging meets all regulatory requirements, protects product integrity, and enhances user experience. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- J&J Family of Companies (Raritan, NJ)
- …a global or multinational setting. + Proven expertise in regulatory labeling , including content development, document management, translations, and digital ... your applications will be considered as a single submission. ** Director , Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs** Are you… more
- Bristol Myers Squibb (Summit, NJ)
- … Labeling is a senior leadership position responsible for shaping and executing global regulatory labeling strategies to support company objectives and ... documents for US, EU, and international markets. The Executive Director oversees labeling management, labeling ...content management. + Participates and drives Global Labeling Policy, partnering with Global Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Under Armour, Inc. (Baltimore, MD)
- Director , Global Labeling & Packaging ** Director , Global Labeling & Packaging** **Values & Innovation** At Under Armour, we are committed to ... theInternal Career Site Here. (https://performancemanager8.successfactors.com/sf/careers/jobsearch?bplte\_company=ua&\_s.crb=aNMP8gWoYkBDFn%252bz2BldysgcgQHZpVs6tHzE9smSuXE%253d) **Purpose of Role** The Director , Global Labeling & Packaging… more
- Bayer (St. Louis, MO)
- ** Director US Labeling & Registration** The Director US Labeling & Registration is responsible for the creation and maintenance of local labeling ... labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations...TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Labeling & Registration, are to:… more
- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , DRA Product Labeling will lead and manage the coordination ... labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling ...labeling section of NDA Annual Reports. **Requirements** Associate Director : + Bachelor's degree with a focus in Biology… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy is responsible for ... and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead ... (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the...regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global...possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of… 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** ... prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling...for the device regulatory strategy, including a global labeling strategy + Ensures alignment and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …standards and departmental policies. The Director , US Product Group Regulatory Affairs will proactively participate in US/ global cross-functional meetings ... Excellence Team, the position holder will provide US regulatory input into the Global Regulatory...Global RA Strategy, Risk Assessments). + Collaborates with US/ Global Labeling on early target label profile… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned ... possible, together. **Job Description** You will act as the Global or Regional Regulatory Lead on more complex or multiple products, compounds, indications… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... Skills + Excellent communication skills including: verbal, reading and writing. + Use various labeling software tools such as TVT and/or Global Vision. Can be… more
