- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , DRA Product Labeling will lead and manage ... 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… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …Preferred **Knowledge and skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid ... labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key… more
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director Commercial Regulatory Affairs** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking 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...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… 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** ... on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …grow and become your best self. Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs** will provide regulatory support ... activities, developing and maintaining documentation for compliance programs such as labeling , promotional material review, and other regulatory requirements.… more
- GRAIL (Albany, NY)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Ascendis Pharma (Princeton, NJ)
- …As a member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and ... boundaries of company compliance SOP's and US regulations). The Associate Medical Director is expected to develop...for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling ,… more
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