- Merck (North Wales, PA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- Charles River Laboratories (Wayne, PA)
- …one or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the ... regulatory requirements. ⦁ Assume a key role in designated Regulatory Affairs and Compliance projects and programs. ⦁ Participate in Corporate Quality… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices;… more
- Pfizer (Collegeville, PA)
- …Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least 8 years. + ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- Sumitomo Pharma (Harrisburg, PA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- The Hershey Company (Hershey, PA)
- …and support small-to-medium sized projects. The positions will be focused on Food Regulatory Affairs and Food Safety Quality. These positions could require ... functions. * Overview of Internship and Potential Projects* * Food Regulatory Affairs * * Food Regulatory Compliance projects * Provide regulatory… more
- Constellation (Kennett Square, PA)
- …+ Strong written and oral communication skills + Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of Sr. ... includes bonus and 401(k). **PRIMARY PURPOSE OF POSITION** Performs advanced regulatory /technical problem solving and provides analysis/insights in support of plant… more
- Organon & Co. (Plymouth Meeting, PA)
- …core labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and ... labeling documents for company products, including Core, US and supporting country regulatory affiliates for consistency of labeling documents around the world. +… more