- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Abbott (Pleasanton, CA)
- …for regulatory approval of new and modified products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to ... requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements,...years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance,… more
- System One (Florham Park, NJ)
- …effectively in a cross-functional team environment. + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH ... and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances + Performance will be monitored...draft submission packages. Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality… more
- Lilly (Indianapolis, IN)
- …Health Canada, team members, and partner companies as appropriate. + Execute high quality communications with FDA , Health Canada, and internal customers to ... for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and… more
- Boehringer Ingelheim (Athens, GA)
- …The Director, US Regulatory Affairs Pharmaceuticals is a key interface with US Regulatory Authorities such as the FDA & EPA and drives regulatory ... reflect Boehringer Ingelheim's high regard for our employees. The Director, US Regulatory Affairs Pharmaceuticals leads the US Regulatory Affairs (RA) Pre… more
- Philips (Plymouth, MN)
- … regulatory issues with RA Management. + Obtaining knowledge in global regulatory requirements. + Following Spectranetics Quality System procedures to ensure ... **Intern - Regulatory Affairs- Minneapolis, MN - Summer 2026** We...CMDR, MDSAP and all other applicable regulations. + Applying FDA , ISO, EU, and other applicable regional regulations **You… more
- Actalent (Irvine, CA)
- … procedures and SOPs. + Collect and organize information on requirements for regulatory , quality , preclinical, and clinical data to meet applicable regulations. ... documents and compliance. + Experience with labeling and regulatory affairs. + Familiarity with FDA and EU MDR. + Strong project management, analytical, and… more
- University of Utah (Salt Lake City, UT)
- Details **Open Date** 11/25/2025 **Requisition Number** PRN43693B **Job Title** Regulatory Coordinator **Working Title** Regulatory Coordinator **Career ... time)** **Job Summary** Develops and coordinates the submission of regulatory documents for the Population Science Trials Office at...effective follow through and compliance of all involved following FDA , Good Clinical Practice, IRB , NIH ,… more
- Jack Link's (Minneapolis, MN)
- …and decision-making skills. + Expert knowledge and experience in food labeling and regulatory affairs, preferably with both USDA and FDA . Working knowledge of ... allows Jack Link's to deliver a wide variety of high- quality , great tasting protein snacks to consumers around the..., Mariani and Local Legends Meat Snacks. The Sr. Regulatory Affairs Specialist is responsible for creating and assuring… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …skills. + Working knowledge of US medical device regulations, 21 CFR 820 Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice ... implantable and absorbable devices. Under the mentorship of the Manager of Regulatory Affairs, the position will provide technical and administrative regulatory … more