- Cardinal Health (Raleigh, NC)
- **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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… more
- Edwards Lifesciences (Raleigh, NC)
- …representative in core team meetings in the development of reporting plans and regulatory submissions . + Lead and provide input on other complex cross-functional ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international… more
- United Therapeutics (Research Triangle Park, NC)
- …CROs + 2+ years of experience in statistical programming aspects required for regulatory submissions related to therapeutic drug development + Must be proficient ... functions, advanced macro language, advanced ODS and SAS/Graph. The Senior Statistical Programmer will lead and support statistical programming activities… more