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We’re immediately hiring a US Regulatory Affairs Lead for Personal Care and Sleep who is proficient in cosmetics, dietary supplements, and OTC products. Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods and medical devices.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. he Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements.
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At least 5 years of experience in a Solution Architect role serving the Regulatory Information Management domain. 7+ years of experience supporting pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings.
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The 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.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.
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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.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Regulatory Affairs Program Lead to support our Wound Closure and Healing portfolio. The Senior Regulatory Affairs Program Lead has end to end responsibility for the life cycle maintenance and new product development launches within the Wound Closure and Healing portfolio.
$105,000 - $160,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization and Operations.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Work with regulatory leads through cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA engagement, labeling and advertising.
$95.7 - $110.7 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Join Our Team as a Remote Regulatory Affairs Specialist II! Qualifications: Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on IND maintenance activities for oncology products.
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Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 8 days ago
Title: regulatory Company: Clarivate Plc in Neshanic Station, NJ
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