- Boehringer Ingelheim (Ridgefield, CT)
- … complexity and/or business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and ... lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director, acts as liaison to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Pharmacology, Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC , Regulatory Affairs , Patient Safety and ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Otsuka America Pharmaceutical Inc. (Hartford, CT)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more