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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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Join Takeda as an Associate Director, Global Regulatory Affairs CMC - Marketed Products where you will be a GRA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout commercial lifecycle.
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As part of the Global Regulatory Affairs CMC team, you will report to the Executive Director, GRA CMC. 8 years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance.
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Provide regulatory CMC expertise for new business development/due diligence activities. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
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The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
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Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as a regulatory associate I/II. This position will be responsible for supporting the Sr. manager of regulatory affairs and assisting in developing and executing regulatory activities in support of the CMC, nonclinical, and clinical development for our early development pipeline products within the Regulatory Affairs department.
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ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey.
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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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Direct Regulatory Affairs CMC experience, ideally in a development environment. Provide regulatory CMC knowledge and progressively growing levels of expertise to TA and non-TA projects within Global Regulatory Affairs(GRA) and AZ technical functions.
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Associate Director, Regulatory Affairs Advertising and Promotion page is loaded.
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Similar Jobs (5) Director, Regulatory CMC, Cell & Gene Therapy (Boston) locations Boston, MA time type Full time posted on Posted 4 Days Ago External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy locations Boston, MA time type Full time posted on Posted 30+ Days Ago Supply Chain Manager - Cell & Gene Therapy (Hybrid) locations Boston, MA time type Full time posted on Posted 25 Days Ago.
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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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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Bachelors degree from an accredited institution with a focus in Chemistry, Pharmaceutics, or Biology preferred, and eight (8) years of technical experience in the pharmaceutical industry dealing and least three (3) years in CMC regulatory affairs.
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This 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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