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Primary Talent Partners has a 12 month contract opening for a Regulatory Affairs Specialist (MDR) with a Medical Device client of ours. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Provides guidance with localization and labeling requirements. This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions.
$180,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
$146Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, (the globe minus US, EU, Canada.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Lead a multidisciplinary labeling working group and provide labeling strategy proposal (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC.
$60 - $63 an hourRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Regulatory Affairs experience with personal care brands cosmetic and OTC. The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Lead for a prominent Pharmaceutical client of ours.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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As part of this opportunity, the incumbent will work with functional groups including Regulatory Affairs, Quality Assurance, Marketing, Packaging and Manufacturing to develop requirements for labeling text.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Position Summary: Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Develop and implement regulatory affairs practices and policies in compliance with quality systems, and to assure adherence to global and regional requirements, and SOPs. Experience with multiple regulatory disciplines (CMC, clinical, labeling, etc.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Work with the Director of Regulatory Affairs to ensure rapid and timely approval of new and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements.
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Strong background with FDA cGXP standards and regulatory requirements for packaging and labeling. Additionally, partner with Marketing and Regulatory to develop and finalize content and product branding elements of packaging & labeling for both the US and Global markets.
ExpandApply NowActive JobUpdated 4 days ago
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