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Dorsey and Whitney LLP is seeking a Regulatory Affairs Associate with four to six years of experience to join the Anchorage office. Among Dorsey’s many distinguished alumni are U.S. Supreme Court Justice Harry Blackmun, noted law professor and scholar William Prosser, Minnesota’s first woman judge Betty Washburn, former U.S. Vice President and Ambassador to Japan Walter Mondale, U.S. Senator Amy Klobuchar, former Corporation Counsel of the City of New York Zachary Carter, and U.S. Secretary of Agriculture Tom Vilsack.
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Comprehensive understanding of related disciplines (biostatistics, regulatory affairs, pharmacology, toxicology, cell therapy manufacturing, clinical pharmacology, and pharmaceutical sciences.
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Scientific Affairs & Regulatory Affairs. The Sr. Scientist II will execute the Scientific Affairs Strategy for your respective categories and geographical area using your Scientific and Regulatory expertise.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
$113 an hourFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
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As time allows, the Manager for Regulatory and Legislative Affairs will also assist in representing the Trust's interests at the Maine Legislature and other policy and regulatory forums.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. BSc in Life Sciences or related scientific discipline with 5+ years of Post Approval CMC Regulatory experience for biopharmaceutical products.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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This role will report to the head of Global Regulatory Affairs and is responsible for overseeing and directing all CMC regulatory support and submissions for late-stage development and commercial products.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The Head of CMC Regulatory Affairs / Associate Director will lead the site Regulatory Affairs function and customer related RA CMC compliance activities. Following our agreement with Roche to acquire the Vacaville manufacturing facility, we are now looking to recruit an Associate Director CMC Regulatory Affairs for the Vacaville site.
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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.
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Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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regulatory affairs jobs Company: Silver City Center Silver City Nm in WA, Ohio
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