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As a Regulatory Affairs Specialist, you'll play a pivotal role in upholding our mission by ensuring regulatory compliance and promoting the well-being of pets worldwide.
$113,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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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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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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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 3 days ago - UpvoteDownvoteShare Job
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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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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. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials.
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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). U.S. Market-Based Salary Range Regulatory Affairs Specialist [$81,700.00 - $108,100.00] In addition to base compensation, individuals may be eligible for an annual discretionary bonus and profit-sharing payout.
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Comprehensive understanding of related disciplines (biostatistics, regulatory affairs, pharmacology, toxicology, cell therapy manufacturing, clinical pharmacology, and pharmaceutical sciences.
$350,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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KNOWLEDGE, SKILLS, and ABILITIES Bachelors in any of the following degrees from an accredited university/college: Regulatory Science, Regulatory Compliance, Regulatory Affairs, Environmental Science, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering.
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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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Flint Group is seeking a Regulatory Affairs Specialist to ensure continuous compliance for industrial ink and coatings products, supporting commercial teams in North America.
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This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
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regulatory affairs specialist jobs Title: compliance specialist Company: Southern Ohio Medical Center
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