- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Clinical Trial Application (CTA) submission deliverables + Manage CTA regulatory submission /document transfers between Regeneron and CROs. This can include ... Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members. **In… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for ... that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head...operations. + Lead the execution of these global CMC regulatory plans, including overseeing the submission and… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Manager, Regulatory Promotional Operations, is a subject matter expert ... to ensure a seamless MLR review process from start to finish. The Senior Manager provides expert guidance on submission timelines and resource requirements,… more
- Publicis Groupe (New York, NY)
- …of a global leader. **Job Description** The Senior Associate, Regulatory Promotional Operations is a project -level lead responsible for independently ... MLR process, facilitating effective communication among cross-functional team members regarding project statuses, advising on submission timelines, and following… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and responses to regulatory agency requests: + develops and tracks submission timelines with RA Project Operations + actively participates in product ... evidence, and creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm),...and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory… more
- Medtronic (Minneapolis, MN)
- … department and other business functions. This position reports to the Senior Regulatory Affairs Manager. **Role And** **Responsibilities:** + Develop and ... MN but a remote worksite may be considered. The ** Senior ** **Principal Regulatory Affairs** will play a...and requirements for global commercialization. + Develop options of regulatory strategies, risks mitigation, issues and submission … more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for... support through the product life cycle on product project teams (eg, developing regulatory strategies, change… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Senior International Regulatory Operations Specialist** will work on-site at our ... glucose levels with our new sensing technology. As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure… more
- West Pharmaceutical Services (Exton, PA)
- …a healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is ... Sr. Specialist, Regulatory Project Mgmt Requisition ID: 66496...(RA) team's priorities. + Manage the preparation, review, and submission of complex global regulatory filings, information… more
- Stryker (Redmond, WA)
- …jurisdiction + Determine requirements (local, national, international) and options for regulatory submission , approval pathways, and compliance activities + ... regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools + Evaluate proposed… more