- Boehringer Ingelheim (Ridgefield, CT)
- …can support projects of increasing regulatory complexity and/or business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is ... to FDA concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected to support projects of… more
- J&J Family of Companies (Raritan, NJ)
- …professional work experience is required. + A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for ... & Johnson Innovative Medicine R&D is recruiting for an Senior Manager, Global Labeling Product Leader. This...in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director, Global Labeling Product Leader is… more
- Takeda Pharmaceuticals (Boston, MA)
- …alignment with TAU/MPD Labeling Lead, coordinates the process to obtain IFU labeling approval by Labeling Senior Management Cross-functional team (Global ... what is possible in order to bring life-changing therapies to patients worldwide. As Associate Director, Global Labeling Devices, you will be responsible for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global ... bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you...and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional… more
- Boehringer Ingelheim (Ridgefield, CT)
- …labeling for NCEs/NBEs and labeling supplements. With minimal assistance from senior labeling management, from a labeling perspective, provides impact ... for potential CCDS updates/proposals: With minimal assistance from senior labeling management, from a labeling...Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents needed for regulatory… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …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 ...Alliance partners, as needed. + Develop clear communications for senior management and labeling stakeholders, to streamline… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and production cleanrooms. + Ensure compliance with NRC, EH&S and US/EU GMP regulatory guidelines as required. + Less than 5% travel required. **Education and ... is highly desirable. **Skills and Qualifications** + Experience with radiometal labeling or radiopharmaceutical synthesis + Experience with wet radiochemistry and/or… more
- Boehringer Ingelheim (Ridgefield, CT)
- …software). + Basic knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines. ** Senior Associate Director:** + PhD in ... programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director/ Associate Director, Pharmacometrics will independently… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Senior Manufacturing Project Lead will lead and organize manufacturing projects and support activities. This manufacturing facility will be ... it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs,… more
- Amgen (Washington, DC)
- … Regulatory Policy and Intelligence Manager** **What you will do** The United States Regulatory Lead (USRL), Sr . Manager is assigned to one or more Amgen ... regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc. +...degree and 6 years of related experience OR + Associate 's degree and 10 years of related experience OR… more
Related Job Searches:
Associate,
Labeling,
Labeling Associate,
Regulatory,
Regulatory Associate,
Sr,
Sr Associate