- 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)
- …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
- Otsuka America Pharmaceutical Inc. (Hartford, CT)
- …with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory operations , etc.) to develop global ... years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Development, Proof of Clinical Principle, Release of Full Development, input into regulatory strategies and labeling discussions). + Provides medical guidance ... external expert's insights, US healthcare dynamics, understanding of the US regulatory environment, and the clinical development experience to translate US medical… more