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This position may work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA, sponsor, etc.
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters, partnering with Platform and OpCo legal counsel.
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Seven (7) years' direct regulatory affairs experience in a biologics, drug manufacturing, medical device facility or FDA regulated environment. Serve as the OPI Regulatory Affairs representative to organizations related to the plasma industry.
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Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
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The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research. Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
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Reviews and provides in-depth regulatory compliance recommendations for all NHG marketing materials including ads, flyers, brochures, consumer reviews, and other published product literature to ensure compliance with FDA DSHEA regulations and FTC guidelines.
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Bachelor’s degree in a relevant field, such as business administration, legal studies, or regulatory affairs. Stay updated on relevant laws, regulations, and industry standards to ensure compliance with 503B, DEA, BOP, DHHS, FDA guidelines.
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Responsible for regulatory compliance of NFP’s, SFP’s and other product label claims Perform other duties as assigned depending upon business needs Skills and Qualifications: FDA Audit experience preferred.
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The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
$155,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Principal Investigator conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes. Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes.
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As the Regulatory Affairs Specialist , you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. We are currently seeking a Regulatory Affairs Specialist to join our Medical Division.
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Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements Prior experience of regulatory interactions, authoring filing IND or BLA experience Understanding of new drug commercialization and business practices Understanding of resourcing and budgeting Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
$256,334 - $318,868 a yearRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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3-5 years of knowledge and experience with a proven track record in Regulatory Affairs and Quality Knowledge in Supplier Quality, Quality, or Manufacturing Engineering, preferably in a medical device environment.
$120,000 - $160,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Boehringer Ingelheim Executive Director, US Regulatory Affairs CREA (CNS, Retinopathies & Emerging Areas) Product Group Ridgefield , Connecticut Apply Now The Executive Director of the US Regulatory Affairs CREA Product Group serves on the US Regulatory Leadership Team responsible for supporting the management of the US RA organization in collaboration with other functional RA leaders (Promo/Adv, CMC RA, RA Operations, Labeling/Labeling Operations, other Product Group therapeutic areas.
$200,000 - $347,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
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