- Chiesi (Cary, NC)
- Global Regulatory Affairs Labeling & Promotional Manager Date: Jan 23, 2025 Department: Global Regulatory Affairs Job Type: Direct Employee ... external departments and health authorities as needed in the activities of the Global Regulatory Affairs group. + Provide input to support trial designs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently ... provides strategic and operational leadership on product labeling in collaboration with Global ...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...as point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...as point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling , coordinates the process ... **Escalation Process and Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Regulatory Affairs Labeling Content Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US ... Affairs and across functions, as a US regulatory labeling advocate to achieve common goals...+ Assist with FDA interactions on assigned projects/products, including labeling negotiations. Interact with Global Labeling… more
- Novo Nordisk (Plainsboro, NJ)
- …teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing ... make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports ... product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved submitted and maintained for… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Microsoft Word / Excel / PowerPoint). + Manages time efficiently. + Knowledge of global Regulatory Affairs requirements. + Strong organizational skills + ... skills, and the ability to multi-task disparate projects + Knowledge of global Regulatory Affairs requirements, regulations, and standards… more
- Amgen (Washington, DC)
- …Affairs Director supporting products in the General Medicine - Cardiovascular Therapeutic Area. Global Regulatory Affairs (GRA) provides global ... global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions, and...Ability to deal with ambiguity + Negotiation skills + Global Regulatory Affairs experience +… more
- Takeda Pharmaceuticals (Columbus, OH)
- …US and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team ... Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory...Labeling cross functional teams including clinical, safety, medical affairs , device regulatory and commercial, to ensure… more
- AbbVie (Irvine, CA)
- …you will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global ... North Chicago, IL offices. + Responsible for leading the Global Regulatory Product Team (GRPT), developing, and...ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling … more
- Integra LifeSciences (Princeton, NJ)
- …in regulatory affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies. + Ability to ... outcomes and set new standards of care. The Director, Global Regulatory Labeling is responsible...+ Bachelor's degree and 7+ years of experience in regulatory affairs , quality assurance and/or labeling… more
- Takeda Pharmaceuticals (Columbus, OH)
- …Escalation Process and Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and ... Labeling cross functional teams including clinical, safety, medical affairs , and commercial, to ensure the highest level of... Team and GRA + Represents Global Labeling at Global Regulatory Team… more
- Merck (Rahway, NJ)
- … labeling to teams. + As the regulatory labeling liaison on global Regulatory Affairs subteams, your input will be essential to our operations. + ... in people and animals. In the capacity of a Global Labeling Lead, you will be instrumental... experience or relevant pharmaceutical industry experience (eg, Medical Affairs , Regulatory Affairs , Clinical, Pharmacovigilance).… more
- Amgen (Washington, DC)
- … Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory ... Director is: + To lead a team within Amgen's Global Regulatory Affairs department +...global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions +… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …success._ Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Manager of Regulatory Affairs , the Specialist of Regulatory Affairs ... expertise to MMS-PA platform. This individual facilitates the regulatory affairs activities within the MMS-PA platform.... Product Development System (GPDS) + Serves as a regulatory expert for labeling and promotional materials… more
- AbbVie (North Chicago, IL)
- …matter expert within Operational Labeling and liaise primarily with Regulatory Affairs , Packaging Engineering and Manufacturing. Ensure tasks are completed ... and key subject matter expert on regulatory , manufacturing, and commercial labeling considerations to ensure the Global Label Management organization meets… more
- Olympus Corporation of the Americas (Westborough, MA)
- …@Olympus.com, it is likely not legitimate._ **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices ... -related matters. Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling...of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of… more
- Lilly (Indianapolis, IN)
- …of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory , and legal. Demonstrate deep knowledge of ... with the strategic priorities of the respective business unit global Medical Affairs team, brand team (s...strategic plan for the compound ), medical support for regulatory affairs and interactions with government agencies… more