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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 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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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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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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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$284,375 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - 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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The Counsel position will be an integral part of the Regulatory, Operations, Government Affairs and Environmental team. The Counsel will assist the Deputy Chief Counsel and Principal Counsel on various transactional, operational and regulatory legal matters primarily for Disney Signature Experiences (with a focus on Disney Cruise Line) and also the Walt Disney World Resort.
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OPPORTUNITY 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 3 days ago - UpvoteDownvoteShare Job
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The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.
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Reporting to the VP of Global Regulatory Affairs, the candidate will build, drive, and direct the company’s regulatory strategy and operations in order to successfully introduce cellular therapies for autoimmune diseases in the clinic.
$270,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month 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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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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The Department of Pharmacology and Toxicology within Developmental Sciences is seeking an experienced regulatory/project toxicologist and strategic leader to develop and lead the execution of nonclinical safety strategy for gene therapy programs at Spark.
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Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) Experience in supporting study-level audits and regulatory inspections.
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regulatory affairs jobs Title: career
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