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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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Senior Director, Business Planning & Operations, Regulatory AffairsThis is what you will do:The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines 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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The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT.
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Cybersecurity Policy Program Director - Global Regulatory Affairs, Strategy, and Policy. Senior Director, Regulatory Affairs, Robotics ID: 240000JW. Senior Director, Regulatory Affairs, Robotics.
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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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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, 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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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
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Reporting to the Dean of Students, this role is responsible for administrative logistics for the Office of Student Affairs (Office of Student Success, Office of Student Services, Residential Life, Title IX, and the Student Center at Harvard Griffin GSAS.
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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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The Director, Regulatory Genomics will have demonstrated expertise in regulatory writing and strategy as well as health authority interactions both written and verbal with a focus on genomics and genotoxicity evaluation.
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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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regulatory affairs jobs Title: sr director Company: Csl Behring in Boston, MA
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