- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking a talented and innovative Intern to join our US Regulatory Affairs Labeling Operations department located at our ... necessary for interacting on a daily basis to address labeling operations related matters with various personnel...management + Student in Pharmacy program or interest in Regulatory Affairs Labeling preferred. **Compensation**… more
- Boehringer Ingelheim (Ridgefield, CT)
- …business processes + Based on organizational need supervise assigned RA Product Labeling Operations staff members **Duties & Responsibilities** + Actively lead ... role for ad hoc project assignments where DRA Product Labeling operations representation is needed. + Independently...Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents, for example, SPL, MS… more
- Gilead Sciences, Inc. (Foster City, CA)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates,...and artwork updates. In this role you will lead labeling operations for global and regional … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …best self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist in Advertising/ Labeling , you will play a crucial ... of products for global release per Regulatory Affairs requirements. * Review and approve labels, labeling...to maintain our culture of excellence and ensure smooth operations , while also recognizing the importance of flexibility and… more
- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance...and driving label development and execution. May also provide Labeling Operations oversight and direction for the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce… more
- Takeda Pharmaceuticals (Boston, MA)
- …guidance pertaining to pharmaceutical drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global ... and EU standards and guidelines. + Responsible for developing regulatory labeling strategies for implementation of new...experience in the biopharmaceutical industry (eg, safety, ad promo, regulatory strategy, medical affairs , etc.). Up to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Labeling at Global Regulatory Team (GRT) - Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead ... to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This **Senior Regulatory Affairs Specialist** will work out of our Alameda, CA location ... the Diabetes Care Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- …and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of ... US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact... labeling reviews. + Collaborates with US RA Labeling Content and Labeling Operations … more