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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs and Clinical Operations.
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Manage preparation of regulatory documentation to facilitate the commercialization of new products in the US and internationally. Maintain dashboard for regulatory approvals for international country license / registration renewals.
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Requirements: Master's degree in Regulatory Affairs, Engineering, Life Sciences, or closely related technical discipline (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or experience executing the complete lifecycle of product registrations before national and international regulatory agencies, including documenting internal processes for quality control, and coordinating post-market surveillance and reporting activities.
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The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout development.
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The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory’s Quality Management System for domestic and various international markets for SaMD products.
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Create/revise SOP’s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes. At least 10 years’ experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review.
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Provide leadership, and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities worldwide in support of INDs, BLAs, MAAs, DMFs, CTRs/CTAs, IMPDs, PIPs, PAERs, amendments, safety reports, and annual updates.
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Entry-level position, but some relevant experience or exposure to regulatory affairs is beneficial. This is Vydehi from Intellectt Inc. We currently have an opening for a Regulatory Affairs Analyst with one of our medical device clients.
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The Work You'll Do:As a Regulatory Compliance Engineer II, you will be primarily responsible for validating the quality and accuracy of the rates and rules contained in our tax calculation engines and related products.
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This is a Heavy Data Migration role, candidates should have Knowledge of Regulatory, Publishing, or EDMS models. Regulatory and/or Parexel Insight Manager knowledge a plus. This is a Heavy Data Migration role, candidates should have Knowledge of Regulatory, Publishing, or EDMS models.
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Guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed. to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled.
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The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (e.g., IND / CTA / IMPD / GMO), registrational filings (e.g., BLA, NDS, MAA, and supplements), and responses to health authority questions/requests.
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In-depth knowledge of Regulatory Affairs strategies with an executive level of experience in the biotechnology and pharmaceutical industry with a focus on rare/ultra-rare disease and orphan drug development and the 505(b)2 pathway.
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Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials. Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review, GI where you will be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
$133,000 - $209,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago
Title: regulatory Company: Flybreeze in Reading, MA
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