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Jobs (18 Matches)
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1. Associate Director/Director, Regulatory Affairs CMC   (Temporary)4 hour(s) ago
Alkermes - United States, MA, North Waltham - Not rated - (view employer jobs)
Categories: Biotech, Pharmaceutical, ScienceJob DescriptionAlkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to ...
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2. Vice President Regulatory Affairs   (Fulltime)7 hour(s) ago
Pentec Health - United States, PA, Clarington - Not rated - (view employer jobs)
Categories: Executive, QA - Quality ControlJob Description Bachelor's Degree 5 or more years of experience Objective: Leads the development, implementation, and direction of effective regulatory strategies with ...
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3. Regulatory Affairs Labeling   (Fulltime)19 hour(s) ago
Aerotek - United States, NJ, Bridgewater - Not rated - (view employer jobs)
Categories: PharmaceuticalJob DescriptionWe have placed one person already in this group and they now have a need for an additional person.This new associate will be Labeling Lead for Consumer Products. * Working with regulatory, marketing, supply chain, and others, review labeling for compliance with FDA / FTC regulations and requirements, ...
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4. Project Manager - Regulatory Affairs   (Fulltime)1 day ago
Pace Analytical Services, Inc. - United States, IA, Coon Rapids - Not rated - (view employer jobs)
Categories: QA - Quality Control, Strategy - Planning, ManagementJob DescriptionProject Manager - Regulatory Affairs ...
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5. VP, Marketed Products   (Fulltime)1 day ago
Mallinckrodt - United States, MO, Saint Louis - Not rated - (view employer jobs)
Categories: ExecutiveJob DescriptionJob TitleVP, Marketed ProductsRequisitionJR000003569 VP, Marketed Products (Open)LocationMKG-Hazelwood, MO (675) - USA037Additional LocationsSt. Louis, MOCompany InformationMallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare ...
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6. Regulatory Affairs Lead (IRC8293)   (Fulltime)2 days ago
Integra Life Sciences - United States, NJ, Plainsboro - Not rated - (view employer jobs)
Categories: Purchasing - Procurement, Inventory, Supply ChainJob DescriptionThe Unique Device Identifier (UDI) Regulatory Affairs Team Lead is responsible for planning, executing, and supervising data collection and management activities for Integra’s Unique Device Identification compliance program. The UDI Regulatory Affairs Team Lead will also contribute to various Master ...
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7. Director Of Regulatory Affairs   (Fulltime)2 days ago
Glanbia Performance Nutrition - United States, IL, Aurora - Not rated - (view employer jobs)
Categories: QA - Quality Control, ManagementJob DescriptionGlanbia Performance Nutrition (“GPN”) is one of the world’s leading sports nutrition providers, and a key division of publicly-traded (LON:GLB), Ireland-based Glanbia Plc (Glanbia), whose dairy and nutritional products are sold in more than 120 countries.  With state-of-the-art production facilities occupying over 500,000 square ...
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8. Regulatory Affairs Manager (Labeling) Perm Opportunity   (Fulltime)2 days ago
System One - United States, NJ, Piscataway - Not rated - (view employer jobs)
Categories: PharmaceuticalJob DescriptionManager, Regulatory Affairs (Labeling) Princeton, NJ Manager, Regulatory Affairs (Labeling) Perm Opportunity Our Client a Global Pharmaceutical Company is seeking a Manager, Regulatory Affairs (Labeling) to join their team. In this critical role, you will ensure regulatory compliance in relation to Labeling and Promotional Review submissions and initiatives. Knowledge of OPDP is critical ...
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9. Senior Director Global Product Safety and Clinical Affairs-Roswell, Georgia or Neenah, Wisconsin   (Fulltime)2 days ago
Kimberly Clark - United States, GA, Roswell - Not rated - (view employer jobs)
Categories: QA - Quality ControlJob DescriptionQuality Jobs – Roswell, GeorgiaQuality Jobs – Neenah, Wisconsin   SENIOR DIRECTOR GLOBAL PRODUCT SAFETY AND CLINICAL AFFAIRS-Roswell, Georgia or Neenah, Wisconsin Requisition number – 1500006V Location: Roswell, Georgia Position Summary: This team leader position reports to the Vice-President of Global Quality and is ...
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10. Regulatory Affairs Senior Manager   (Fulltime)2 days ago
Xellia Pharmaceuticals - United States, NC, Raleigh - Not rated - (view employer jobs)
Categories: QA - Quality ControlJob Description US Agent for Xellia to the Agency Maintenance of Xellia Drug Establishment Registrations (DER) covering all sites ...
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11. Mgr / Sr. Manager Regulatory - Medical Device   (Fulltime)3 days ago
Acumen Executive Search - United States, OR, Portland - Not rated - (view employer jobs)
Categories: Management, Biotech, ScienceJob DescriptionManager / Sr. Manager Regulatory for Global Device Manufacturing  Acumen Executive Search is a boutique recruiting firm specializing in finding the right person for our client companies. Our clients enjoy a rise in retention and productivity and lowered expenses due to the quality of candidates ...
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12. Regulatory Manager (10261)   (Fulltime)3 days ago
Givaudan - United States, NJ, East Hanover - Not rated - (view employer jobs)
Categories: ManagementJob DescriptionAs a Regulatory Manager, Global Data Intregity, you will be an integral part of the Regulatory Affairs & Product Safety (RAPS) team reporting directly to the Head of Global Data Integrity. You will ensure the reliability and integrity of regulatory analysis and data used for compliance and safety ...
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13. Regulatory Affairs Project Manager   (Fulltime)4 days ago
Globus Medical - United States, PA, Audubon - Not rated - (view employer jobs)
Categories: Biotech, Health CareJob DescriptionThe Project Manager assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products ...
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14. Global Labeling Manager   (Temporary)4 days ago
The Ascent Services Group - United States, CA, San Rafael - Not rated - (view employer jobs)
Categories: Admin - ClericalJob DescriptionGlobal Labeling ManagerSan Rafael, CARegulatory/PharmacovigilanceJob Description Preparation of labeling content based on source documents such as Clinical Study Reports (CSRs), regulatory requirements and other reference documents. Review worldwide labeling against the core company safety information and facilitate and track implementation of core labeling changes. Document control and distribution of ...
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15. Director Regulatory Technology & Operations   (Fulltime)5 days ago
Advanced Clinical - United States, NJ, Princeton Junction - Not rated - (view employer jobs)
Categories: PharmaceuticalJob DescriptionJob Number: 426800Director Regulatory Technology & OperationsOVERVIEWServes as the lead for the Regulatory Operations group. Collaborates with other non-clinical and clinical development functions for all therapeutic areas to drive the timely delivery of all FDA and EMA, and Health Canada (supporting) submissions in accordance with applicable governmental regulations ...
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16. CMC Regulatory Manager   (Temporary)5 days ago
CSG, Inc - United States, PA, King Of Prussia - Not rated - (view employer jobs)
Categories: PharmaceuticalJob DescriptionThe scope of the work is to partner with CMC Regulatory Affairs personnel by reviewing historical CMC registered files (BLAs/supplements/amendments) and authoring/compiling compliant CTD formatted documents within project timelines and with limited oversight. Job Requirements• Minimum of a bachelors degree in a scientific discipline plus 3 or more years ...
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17. REGULATORY MANAGER   (Fulltime)7 days ago
Corporate Search Consultants - United States, MN, Minneapolis - Not rated - (view employer jobs)
Categories: QA - Quality Control, ManagementJob DescriptionThis company is a leader in their market and has been taking market share from competitors. This person will have a lot of autonomy - the manager is hands-off. Employees can create improvements and advance them quickly because there isn't a lot of ...
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18. Regulatory Affairs Associate Director   (Fulltime)7 days ago
CSG, Inc - United States, IA, Cincinnati - Not rated - (view employer jobs)
Categories: PharmaceuticalJob Description Associate Director, Regulatory Affairs DESCRIPTION OF JOB DUTIES Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage the process from inception to approval; Interact with FDA, including preparation of PMA/IDE/510K submissions; Manage relationship ...
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