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At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products. As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms.
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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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The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts. The Senior Regulatory Affairs Manager, in collaboration with the Director, LRAC, will lead the federal advocacy efforts through trade associations, including America's Health Insurance Plans (AHIP.
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Act as the primary legal subject matter expert, reference and point-of-contact for the Technical Operations functions at Sana, including Manufacturing, Quality, Process Development, Supply Chain & CMC Portfolio, External Manufacturing, External Supply & Procurement, CMC Regulatory Affairs, Analytical Development & Operations and other Technical Operations teams.
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Knowledge of global regulations is necessary to provide regulatory affairs support to ongoing global clinical trials and to review global submissions to these trials. 8-10 years of relevant pharmaceutical/biotechnology industry experience including 6+ years of experience in Regulatory Affairs related development of pharmaceuticals; phase 1 through NDA and post-approval.
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This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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Associate Regulatory Affairs Specialist. Sr Regulatory Affairs Spec. Senior Regulatory Affairs Specialist. Regulatory Affairs Specialist.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. 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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The VP CMC Regulatory & Quality will lead all aspects of CMC Regulatory Affairs to support global regulatory submissions as well as CMC Quality Assurance and Quality Control for Invivyd’s clinical candidates and commercial products.
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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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Collaborates with Government Regulatory Affairs, Network Management, Medical Economics, Benefit Administration, Provider Services, Audit, IT and Claim Operations to determine the impact of implementing policy changes.
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In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities and ensure timely submission of expedited safety reports. Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
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Reporting to the Chief Medical Officer, the Senior Director of Regulatory Affairs will be responsible for the development and execution of Sails regulatory strategy and operations.
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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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regulatory affairs jobs Title: sr regulatory affairs associate in Boston, MA
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