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The Associate Director, Regulatory Affairs (CMC) works closely with the manufacturing department and individual program teams to ensure CMC compliance and promote overall regulatory success.
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Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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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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Associate Director/Associate Principal Scientist - Regulatory Affairs International Chemistry Manufacturing & Controls. Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product Lead page is loaded.
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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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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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Year over year, MicroVention continues to have best-in-class conversion rates, converting interns in the following departments: Human Resources, R&D, Legal, Corporate Communications, Manufacturing, Quality, Regulatory Affairs, Accounting/Finance, Marketing, and Talent Development.
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Develop business case of new biomarker and diagnostics in collaboration with relevant function, e.g., Clinical development, Regulatory, Medical affairs, Market access, Marketing tumor leads, Manufacturing, and global teams (biomarker and tumor team.
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Lead late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
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The Associate Director will provide management to a team of scientists and/or engineers, Vaccine and Biopharmaceutical process improvement/troubleshooting in support of commercial antigen/antibody manufacturing and sterile biopharmaceutical product fill-finish, and Technology Transfer.
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Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders, including but not limited to Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.
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We currently have an immediate opening for a Regulatory Affairs Associate at Prinston Pharmaceuticals Inc., located in Somerset, New Jersey. Regulatory Affairs Associate.
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The Associate Director of Regulatory Affairs is responsible to independently support new product development and certain geo-expansion activities by developing pre- and post-approval Chemistry, Manufacturing.
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Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
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