- Cardinal Health (Annapolis, MD)
- **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
- Edwards Lifesciences (Baltimore, MD)
- …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
- Johns Hopkins University (Baltimore, MD)
- …operations of the program. **Specific Duties and Responsibilities** + Assists the Start Up Specialist new study IRB submissions as needed. + Ensures smooth study ... specialist , PI and research RN and collecting all regulatory documentation. + Work closely with the Protocol compliance...For IND studies, maintain accurate and up-to-date documents and submissions . + Facilitate the full cycle of the protocol… more