- Cardinal Health (Frankfort, KY)
- …committed to making a difference for our customers and communities. **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory ... and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though… more
- PNC (Pittsburgh, PA)
- …be performed remotely, at manager's discretion. The opportunity lies within PNC's Regulatory Reporting department, specifically the Finance Data Submissions team ... success. As a Sr. Business Analytics Consultant within PNC's Regulatory Reporting organization, housed within the Office of the...for filing the Federal Reserve FR Y14Q/M CCAR data submissions . This role is an opportunity to navigate the… 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 various areas of the business. This could include… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... PMA submissions a plus + Experience assessing regulatory impact of product/process changes + Experience reviewing labeling, promotional literature, etc. +… more
- Fresenius Medical Center (Waltham, MA)
- …operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals ... preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health… more
- Fresenius Medical Center (Waltham, MA)
- …pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions . + Collaborate with senior leadership in ... and potential risks to inform decision-making across the organization. + **Global Regulatory Submissions :** + Oversee the planning, preparation, and execution of… more
- J&J Family of Companies (Cincinnati, OH)
- …product development stages and generating submission ready documentation and authoring regulatory submissions . Additionally, this individual will support health ... , IDEs, De Novo, 510(k)s) and global health authorities' submissions technical documents. + Serves as a Regulatory... submissions technical documents. + Serves as a Regulatory Affairs subject matter expert on new product development… more
- Abbott (St. Paul, MN)
- …Additionally, will coordinate preparation of well organized, complete and scientifically sound regulatory submissions as well as interface directly with various ... Demonstrate excellent project management skills to plan for, lead and author regulatory submissions in key markets (including US and EU) for new, complex… more
- Hologic (Newark, DE)
- …Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment ... with the international regulatory affairs group to support regulatory submissions worldwide for medical devices and includes support of product changes… more
- AbbVie (North Chicago, IL)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
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