- Merck (Cambridge, MA)
- …and model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams. + Collaborate with other functional areas, as ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational background in… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection ... the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review current reporting period against historical data to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …reporting of clinical pharmacology studies. + Extensive experience in late-state drug development, regulatory submissions and life-cycle management. + Hands-on ... sciences, pharmacometrics, statistics and programming). + Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation… more
- Catalent Pharma Solutions (Chelsea, MA)
- …quality of final products. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 4 years of experience in job offered or ... Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … submissions and/or national or international presentations + Excellent understanding of drug development, regulatory processes and clinical development + Strong ... Translational sub team (TST) partnering with Gastro-Intestinal & Inflammation drug discovery unit (GI2-DDU) research scientists, Gastro-Intestinal & Inflammation… more
- Guidehouse (Silver Spring, MD)
- …within a multi-disciplinary organization. **What Would Be Nice To Have** **:** + Drug regulatory experience is desired, particularly in regulatory science ... the validation and implementation of analytical chemistry methods for use in regulatory labs + Support the development of single laboratory and multi-laboratory… more
- J&J Family of Companies (Titusville, NJ)
- …of medical publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug /device regulatory strategies ... reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project physicians. Team… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as evolving regulatory trends and developments for their impact on drug and device development activities and on existing development strategies. + Lead requests ... policy context for business decisions. + Provide strategic regulatory advice to RA colleagues on drug ...strategic regulatory advice to RA colleagues on drug development and device projects, registration, and marketed products… more
- Merck (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... ability to understand how MIDD can drive portfolio and regulatory decisions + Deep knowledge of drug ...and regulatory decisions + Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills… more
- J&J Family of Companies (Raritan, NJ)
- …clinical team members + Assists Regulatory Affairs in the development of drug regulatory strategies + Participate on and may lead cross-functional teams for ... clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues… more