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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 Yesterday - UpvoteDownvoteShare Job
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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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Under the general direction of the Director of Clinical Research, Administration, and Finance of the Center for Clinical Research (CCR), and the Assistant Director of Clinical Research Operations, the Regulatory Affairs Manager (RAM) is responsible for all clinical research regulatory matters in fulfilling the mission of CCR under the University Of California Irvine School Of Medicine and the overall UC Irvine Health enterprise.
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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 for preparing CMC regulatory strategies that enable first pass approvals.
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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 Today - UpvoteDownvoteShare Job
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Minimum seven (7) years customs brokerage, customs consulting, regulatory or similar professional services is required. Actively manage and continuously develop a team of compliance professionals providing day to day support of regulatory and compliance-based inquiries.
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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.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
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The position is responsible for leading CMC regulatory activities within Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products. Work collaboratively with Pharmaceutical Science for drug substance and drug product development, GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Position Title: Senior Regulatory Affairs Associate, New Product Development. In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products and claims in labeling.
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Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.
$306,700 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
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Relevant professional experience includes government, private sector, commercial contracting, or regulatory affairs, international development, international business, or finance with an emphasis on contract and/or grant management cost analysis and pricing, management consulting, or public and/or nonprofit administration.
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Mammoth is hiring aDirector/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
$260,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: care Company: Travelnursesource in Mililani-town, Hawaii
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