- Cedars-Sinai (Los Angeles, CA)
- …fuels innovation and the gold standard of care we strive for. The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory ... reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing… more
- Taiho Oncology (Princeton, NJ)
- …(TPC) and external consultants/contractors. Manages the development and preparation of high- quality regulatory submissions including NDA's, MAA's, INDs, CTAs, ... and other related areas. + In conjunction with Quality Assurance, manages regulatory compliance for sponsor...+ Knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA . + Experience… more
- GRAIL (Concord, NH)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- 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