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Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years’ experience in Regulatory Affairs; or. Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years’ experience in Regulatory Affairs.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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As a Regulatory Affairs Project Manager you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals, and utilize agile principles to drive regulatory activities for our Companion Diagnostics Group (CDx.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Bachelor or Master’s Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred) 2-3 years’ experience in the pharmaceutical industry with 1-2 of those years in regulatory affairs preferred.
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We're looking for a Regulatory Affairs Specialist III, working in Pharmaceuticals and Medical Products industry in Bridgewater, New Jersey, United States. Contributes to the development and oversees the successful implementation of regulatory strategies for assigned products, including submission and maintenance activities related to BLA applications.
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Support Medical affairs team meetings. Medical Affairs experience. 5+ years of Pharma IT Project Management. Must be willing to be on-site in Basking Ridge, NJ at least once a week. Proactively drive, organize, and manage the process to develop programs' tactical planning, and programs' performance/impact measurements.
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Prior experience with performance improvement initiatives, and regulatory oversight, Knowledgeable about state, federal, and regulatory agency requirements, Director for Quality, Safety and Regulatory.
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Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial. Responsible for the development and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project teams.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities. Master Degree (MS/MA) Regulatory Affairs or Science - Preferred.
Full-timeExpandUpdated 28 days ago - UpvoteDownvoteShare Job
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Senior Director - Regulatory Affairs. Facilitate and maintain correspondence with the FDA on behalf of sponsor which may include hosting meetings, phones, calls and/or other necessary regulatory documentation.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area. 3-5 years as a Regulatory Affairs professional working on medical device projects.
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The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Provide interpretation of regulatory authorities' feedback, policies and guidelines.
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Works closely with the Regulatory Affairs labeling group in order to assess and determine the impact of proposed labeling changes on product promotion. Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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External Affairs and Policy. Director Quality, Safety and Regulatory. CPHQ-Certified Professional in Healthcare Quality highly desirable, External Affairs and Policy. Strong leadership, critical thinking, teaching, facilitation, coaching, mentoring and project management skills.
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Travel %: 10% Pay: $111,000 to $192,050 What you will doThe Regulatory Affairs Manager is responsible for regulatory project responsibility for products across needs-states across the Skin Health & Beauty Segment, which may include oversight to key brands such as (NEUTROGENA, AVEENO); covering a wide range of Regulatory classifications (OTC NDA drugs, OTC Monograph drugs, Cosmetics, Medical Devices, and Dietary Supplements.
ExpandApply NowActive JobUpdated 8 days ago
Title: regulatory affairs Company: Sanofi in Bridgewater, NJ
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