- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with key PRB cross-functional stakeholders, especially with Medical Directors, Marketing, Marketing Operations , Legal, Regulatory Affairs and externally with ... throughout NNI and at external agencies. Key internal relationships include Marketing Operations , Marketing, Legal, Regulatory Affairs , Medical Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations , Medical Information,… more
- Formation Bio (New York, NY)
- …and preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations ) to ensure alignment on ... Collaborate with and provide Quality oversight to contract manufacturing, packaging/ labeling , and testing partners. Support the development and maintenance of… more
- 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
- 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...needed for submissions with other departments (eg, RA Product Labeling Operations , RA Operations , and… 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
