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Regulatory CMC experience in authoring and review of (IND, CTA, BLA, MAA) with a drug-device combination product. Regulatory CMC experience in medical device and combination product research, development and/or manufacturing.
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The Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the lives of patients around the world.
$104,000 - $178,000 a yearFull-timeExpandUpdated 2 days ago - UpvoteDownvoteShare Job
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Associate) Director, US Regulatory Affairs, Advertising & Promotion - Permanent - MA, NC, GA Proclinical is seeking a (Senior/Associate) Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in Georgia, North Carolina and Massachusetts.
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Minimum of 3 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry. Certification in Regulatory Affairs. Job Summary: Instrumental in navigating the complex regulatory landscape of biotechnology products.
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Job title: Global Regulatory Affairs LeadLocation: Cambridge, MA or Bridgewater, NJAbout the jobThe Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives.
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Serves as the Regional Regulatory Lead (RRL) for assigned drug development programs. Must possess at least six (6) years of relevant regulatory experience and eight (8) years of experience within the pharmaceutical or biotechnology industry.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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The Associate Director, Regulatory Affairs serves as a Health Authority liaison and key member of project teams, establishes and communicates regulatory strategies for development programs, and coordinates the timelines, generation, and submission of complex regulatory dossiers.
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We are seeking a highly skilled, and experienced AD/Director of Regulatory Operations & Affairs to join our growing clinical team. Bachelor's degree in life sciences, pharmacy, or a related field with a minimum of 7-10 years of experience in oncology regulatory affairs within the biopharmaceutical industry.
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10 years of relevant professional experience, including at least 3 years in Regulatory Affairs in a U.S. advertising and promotion role. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s.
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You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialisation teams, Public Affairs, Legal,Investor Relations, etc.
$177,000 - $259,600 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Associate Director Level: Minimum of 7 years in the pharmaceutical industry, with at least 4 years dedicated to regulatory labeling. Contribute to or lead strategic initiatives, ensuring compliance and alignment with global regulatory requirements.
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Working closely with the Global Regulatory Lead, Regulatory Operations, and cross-functional teams, the Senior Manager will ensure timely submission of high-quality data packages to global health authorities.
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Senior Manager, Global Regulatory Affairs - US Strategy. Minimum 5 years professional working experience in Clinical Regulatory Affairs. Establish and maintain proper regulatory processes for the regulatory handling and lifecycling of clinical trials, in alignment with Global Regulatory Operations and Clinical Research Organizations as appropriate, to ensure regulatory documentation is properly maintained according to internal SOPs, regulatory requirements and best practice.
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affairs job Title: regulatory affairs in Cambridge, Anoka, Minnesota
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