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The Director / Sr. Director, Regulatory Affairs will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination product.
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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.
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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 role will report to a Vice President and Associate General Counsel, Global Risk and Regulatory Affairs, based in Washington DC. Visa is seeking a regulatory attorney to join its growing Global Risk & Regulatory Affairs group to proactively provide regulatory support to Visa’s Commercial & Money Movement Solutions (CMS) business.
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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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Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsDuration: months (we would like to start with months, with the potential to extend if the person is highly competent and a good resource for our team)Location: Remote but preference is to have a candidate available to be onsite at the Foster City, CA offices - days if possible RESPONSIBILITIES MAY INCLUDE.
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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 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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All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. In addition, this individual will ensure robust and healthy communication with internal CMC and clinical teams including QA, QC, Regulatory Affairs, Supply Chain, and clinical operations to fulfill Structure Therapeutics’ commitment to patients and regulatory filings.
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The Chief External Affairs Officer will lead our communications strategy and play a pivotal role in advancing IFA/CB’s mission to effectively and equitably leverage federal funds with private capital to support clean energy products and initiatives across Illinois.
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D., Masters and Ph. D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology- RAC certification a plusExperience:- 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
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OPPORTUNITYMammoth 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 - UpvoteDownvoteShare Job
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Recognized as one of the nation’s top independent communications firms and a pacesetter in industry best practices, FHA specializes in reputation management, corporate communications, policy advocacy, regulatory challenges, litigation support and public outreach campaigns for a blue-chip client roster.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Studies Program aims to advance the discussion of American foreign policy and international affairs through its writing, publications, public outreach, and discussions. CFR also publishes Foreign Affairs, the preeminent magazine on global issues, and provides up-to-date information about the world and U.S. foreign policy on its award-winning website, CFR.org.
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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. An advanced degree and regulatory affairs certification are desirable.
$230,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Company: Focus Staff in Lexington, Massachusetts
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