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Director, CMC Regulatory Affairs. 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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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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Reporting directly to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible role in advancing CMC. Directs and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee.
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The Senior Manager, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will be responsible for working with internal and external constituents to develop and advocate Federal energy regulatory and market policy positions on behalf of Constellation.
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Director, CMC Regulatory Affairs – Biologics. Associate Director, Regulatory Affairs Advertising and Promotion page is loaded. Associate Director, Regulatory Affairs, Labeling.
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Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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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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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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Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
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The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
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Serve as the Plan’s internal Compliance point of contact for Regulatory Affairs matters. Under the direction of the Manager, Regulatory Affairs assist in preparing the Plan for regulatory audits.
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Reporting to the Director in Regulatory Chemistry, Manufacturing & Controls (CMC), the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned products in accordance with global regulations, guidance's, and defined regulatory strategies.
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Title: senior director regulatory affairs Company: Galera Therapeutics
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