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Responsibilities The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies. The Regulatory Affairs Associate will serve as a liaison for PI(s)/study team and various internal/external regulatory oversight groups.
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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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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriad’s gene therapy product development, registration, and post-approval strategies.
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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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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
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The Manager/Associate Director, Health Economics and Outcomes Research (HEOR) Hepatology/Virology will join a high caliber team to execute HEOR strategies and tactics for Hepatitis C and early pipeline assets in virology.
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10+ 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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BryceTech is looking for an experienced Regulatory Affairs Analyst to support the DHS FEMA, Office of Response and Recovery, CBRN program, supporting the Office of Emerging Threats Professional and Technical Services Contract.
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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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Senior Regulatory Affairs Specialist. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices.
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Regulatory affairs experience in the medical device industry with a track record of successful submissions.
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The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company. The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Title: regulatory affairs associate Company: Inventiv Health Clinical
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