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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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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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Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross‐functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity compounds.
$149,300 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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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 17 days ago - UpvoteDownvoteShare Job
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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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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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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 1 month ago - UpvoteDownvoteShare Job
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Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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More details on our benefits can be found on our website at 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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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 1 month ago - UpvoteDownvoteShare Job
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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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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
$218,500 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.
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This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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regulatory affairs jobs Title: specialist Company: Beigene
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