- 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... progress. The Associate Director , Global Regulatory Affairs - Global Labeling ... function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements (FDA,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... You will provide strategic input and management oversight of regulatory labeling activities for multiple products across...new therapeutic areas. + Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs… 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
- 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 ... applications will be considered as a single submission. ** Director , Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs** _Johnson… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As a key leader within Global Labeling Operations, the Director , Labeling Council and ... change impacts their ways of working. + Partner with key stakeholders, including Global Labeling , EUCAN Regulatory Liaison and GEM Area Heads to enable… more
- Bayer (Whippany, NJ)
- ** 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
- Lilly (Indianapolis, IN)
- …around the world. **Responsibilities** The Associate Director of the Packaging & Labeling Group in Global Packaging & Robotics is responsible for leadership ... and continuous improvement + Effectively partner with key customers to include Regulatory , DDCS, IDM, Corporate Engineering organizations, Global Logistics, ETC,… 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
- J&J Family of Companies (Titusville, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Director , Global Regulatory Leader. This position is a hybrid role and ... Titusville, NJ; Raritan, NJ; or Spring House, PA. The Director , Global Regulatory Leader will...programs and for the target label. + Provide integrated global labeling and filing strategy for assigned… 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
- 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 (Morristown, NJ)
- **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
- Candela Corporation (Marlborough, MA)
- ** Director , Global Regulatory Affairs** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** ... distributors in over 60 other countries. **General Summary** The Director , Global RA will be fully accountable... submission/approval dates. + Developing and maintaining partnerships with global regulatory agencies and act as Candela's… 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
- 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
- Chiesi (Boston, MA)
- …and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and ... changes to existing labeling , and submission of labeling information to regulatory authorities in the...regulatory compliance. Knowledge of Common Technical Document and global guidelines on content and format of labeling… more
- Oura (San Francisco, CA)
- …and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor on FDA, EU ... gather informally at local co-working locations. The AGC, Senior Director of Regulatory Compliance & Privacy will...enforcement matters, including FDA warning letters, FTC inquiries, and global regulatory audits. + Monitor evolving … 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
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