- Cardinal Health (Trenton, NJ)
- **What Regulatory Submissions Operations contributes to Cardinal Health** Regulatory provides regulatory affairs and product development consulting ... subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. … more
- Bausch Health (Bridgewater, NJ)
- …creates it-where your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Bayer (Whippany, NJ)
- …facilitate improved collaboration. **Lead the preparation and/or review of IVD/CDx regulatory submissions (SRD, 510(k), IDE, PMA/CE-marking) to support clinical ... to make a real difference, there's only one choice.** ** Senior Director, Global Regulatory Leader-IVD** The ...In Vitro Diagnostics is required; + Solid experience leading regulatory submissions for IVD/CDx, including for use… more
- TD Bank (Mount Laurel, NJ)
- …to multiple stakeholders. Teammates interact directly and independently with auditors and regulatory agencies and provides approval for document submissions to ... with staff and senior management of the Bank with respect to regulatory risk matters. + Empowered to make prudent professional decisions in rendering advice and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …other teams + Setup and track submission content tracker for regulatory submissions and work with Documentation Specialist /PM/ Regulatory CMC to maintain ... aligned with regulatory strategy for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions based on… more
- Sanofi Group (Bridgewater, NJ)
- …structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications ... you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as...for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the… more