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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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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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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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Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred.
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The Director, Regulatory CMC (Chemistry Manufacturing Controls) leads a cell therapy combination product program from development through commercialization through the execution of global regulatory CMC strategies for investigational and marketed products.
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Collaborating with the System Department, Fidelity Retail Investment Service, Product/Project Managers and Administration and Government Affairs to determine development goals, market trends for commissions, prioritize commission enhancements, and review any legal ramifications of these new developments.
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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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The role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and sophisticated product ranges from the development phase through to global launch and post-approval lifecycle management.
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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 Director must understand the entire preclinical and early clinical product development pipeline including product optimization, preclinical scale-up, and manufacture and toxicology, regulatory affairs, and early human clinical trials.
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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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This role will also work closely with global and regional (Osaka, Japan [SHQ]; Florham Park, New Jersey [SI]; and London, England [SEU/SBV]) cross-functional team members including Medical Affairs, HEOR, Clinical Development, Regulatory, Market Access, Commercial teams and external collaborators/vendors to lead and conceptualize research questions, propose study designs, identify appropriate databases, write and review protocols, oversee data analyses, reports, presentations, and publications.
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Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans. Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC.
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Associate Director/Director of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to (Bio)Pharma product development, especially biosimilars, preparing and reviewing submissions.
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Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, or related field with at least 8 years of experience in vaccine and/or biopharmaceutical Development, Process/Product Development through Validation, Management, Technology Transfer, Biopharmaceutical large scale Lyophilization, and/or Biological manufacturing or closely related field OR; Master of Science degree and at least 6 years of experience.
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