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What we look for: 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 organizational leadership skills at both functional and enterprise levels.
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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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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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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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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.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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We are looking for an Associate Director/Director, Regulatory Affairs CMC to join our team. Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced science-related degree.
$169,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to Jefferson’s Central Region Chief Clinical Officer (CCO), the CMO/CQO is an integral member of the TJUH hospitals leadership team providing oversight and leadership on Medical Staff Activities & Affairs, Regulatory Affairs, Quality and Safety, and Clinical Development and Operations.
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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
$57.78 - $62.5Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development to ensure timely delivery and successful commercialization of late-stage portfolio.
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Guides, directs and evaluates (1) Associate General Counsel, (3) Lease Administration Department (1) Senior Paralegals and, (2) Scientific & Regulatory Affairs Department. Provide guidance to Scientific and Regulatory Affairs on regulatory issues related to both product and procedures, including label safety, use of third party literature, and training documentation.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldex’s therapeutic development programs. Industry experience of 10 years, of which at least 8 years spent in regulatory affairs with CMC responsibilities.
$150Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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I have a talented group of recruiters who specifically source Technical Sales Professionals, Scientists, Regulatory Affairs, Scientific Affairs, Executive Technical professionals, Quality Assurance, Product Development, Technical Service, Nutrition, Analytical and Corporate Chefs.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$143,300 - $286,700 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs in WA, Ohio
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