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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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We are seeking a global Executive Director, Regulatory Affairs, Cell Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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SES is hiring an (Associate) Regulatory Counsel to support our Regulatory Affairs & Government team in the Legal Department. Finally you will support other regulatory, policy and advocacy initiatives as may be assigned including those associated with transactions, mergers and acquisitions, and key customers as well as sanctions, privacy, antitrust, export control, cybersecurity, and more.
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Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facilityLead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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Provide regular reports on ERCOT activities to internal stakeholders in Regulatory Affairs, Legal, Transmission, and Wholesale Power. Nine or more years of experience in engineering, business analysis, project management, regulatory analysis, regulatory compliance or other relevant experience.
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The Senior Grassroots Manager reports directly to the Vice President of Regulatory, Labor and State Affairs but collaborates closely with all members of ABC’s Government Affairs team.
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The OpportunityThe Regulatory Affairs Manager will work out of either our Plymouth, St. Paul or Maple Grove, MN locations for our Electrophysiology division. This Regulatory Affairs Manager may analyze broad scope implications of changing regulations and guidance.
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The Verantos Evidence Platform leverages data science and artificial intelligence (AI) along with advanced data sources such as electronic health records (EHR) to generate RWE capable of supporting complex clinical studies in areas such as market access, HEOR, medical affairs, and regulatory engagement.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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The Student Affairs portfolio includes but is not limited to, the VPSA Office, Dean of Students Office, Center for Student Leadership and Engagement, Fraternity/Sorority Life, Office of Community and Ethical Standards, Campus Recreation, Office of Advocacy and Success, Student Health and Wellness Services, Campus Reservations and Events, Student Affairs Business Operations, Military and Veteran Engagement, Residential Living and Resident Learning.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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regulatory affairs jobs Title: regulatory project Company: Jobget
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