- Pall (Miami, FL)
- …for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions , negotiate the resolution of agency questions, and secure ... Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply to… more
- Cardinal Health (Lansing, MI)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... to provide services in technical writing, scientific data verification, and basic regulatory submissions within the discipline of chemistry, manufacturing, and… 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
- Medtronic (Mounds View, MN)
- …and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support ... + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. +… 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
- Cardinal Health (Topeka, KS)
- …applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process ... and risks for products and develops plans for product development programs and regulatory submissions . **_Job Summary_** The Manager, Regulatory Affairs… more
- Fresenius Medical Center (Tampa, FL)
- …operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals ... Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with… more
- Eurofins (Davis, CA)
- …follow-up of submissions under review + Coordinate, prepare, or review regulatory submissions for domestic or international projects + Interpret ... technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation +… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... field and 4 years of prior experience. Prior experience must include: Regulatory submissions to US FDA, EU, and other international health authorities: Manage… more
- AbbVie (North Chicago, IL)
- …under limited management supervision. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new market ... CMC regulatory product strategies with limited supervision. + Prepares regulatory submissions , including new applications and amendments, renewals, annual… more
Recent Jobs
-
SAP Developer
- NVIDIA (Santa Clara, CA)
-
Diesel Technician - $4,000 Sign On Bonus!
- Leonard Bus Sales, Inc. (Saratoga Springs, NY)
Related Job Searches:
Regulatory,
Regulatory Submissions Coordinator,
Regulatory Submissions Manager,
Senior Coordinator Regulatory Submissions,
Specialist Regulatory Operations Submissions,
Specialist Regulatory Submissions,
Sr Coordinator Regulatory Submissions