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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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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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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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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.
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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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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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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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The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The Senior Manager, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy. Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products.
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A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC. Role Title: Associate Director/ Director Regulatory Affairs CMC.
$230,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
regulatory affairs cmc continuous improvement jobs Title: regulatory affairs manager
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