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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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I-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. Lead Mechanical Engineer / LME. Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a well funded site that will be growing over the next 3 years.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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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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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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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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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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I have a talented group of recruiters who specifically source Technical Sales Professionals, Scientists, Regulatory Affairs, Scientific Affairs, Executive Technical professionals, Quality Assurance, Product Development, Technical Service, Nutrition, Analytical and Corporate Chefs.
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Partner with Government Affairs to help positively shape the legal and regulatory landscape. Experience in other areas of law such as employment law, regulatory law, privacy, corporate law, or litigation would be a plus, but is not required.
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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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And advise MFA on various legislative and regulatory initiatives before Congress, federal agencies (such as CFTC, SEC, Treasury/IRS, the Federal Reserve Board, and state officials), as well as certain private sector industry groups.
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The Massey Comprehensive Cancer Center has an exciting opportunity for an Regulatory Affairs Coordinator to join our team! Ensure safety of research participants and endeavor to minimize risk to the institution, center and PI by maintaining audit-ready regulatory files at all times and uploading currently approved protocols, informed consents and PRMC approvals in OnCore upon receipt.
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The Product Safety Toxicologist will report directly to the Regulatory Affairs Director. We are seeking an experienced regulatory toxicologist as a Product Safety Toxicologist for our global Regulatory Affairs organization.
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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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Our Global Privacy and Regulatory Affairs team provides key support for all of TikTok’s innovative initiatives, state-of-the-art products, and integrated platforms servicing our global video market.
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regulatory affairs jobs Title: intern Company: Fleishman Hillard
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