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Associate Director, Regulatory Operations-hybrid
Location:
Abingdon
Description:
Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U. K. - and U. S. -based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations. Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer. PRIMARY RESPONSIBILITY This role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices. The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner. Key Responsibilities Collaborate with the regulatory team, and cross-functional team members and external contractors/vendors/consultants as needed, to support the planning, preparation, formatting, publishing, QC, submission and archiving of global regulatory submissions (i. e. INDs/CTAs/BLAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc). Provide project management support in generation of timelines for Regulatory interactions and submissions Organize, archive, and track Health Authority correspondences, submissions, and questions/commitments Collaborate with our external publishing vendor(s) on submission publishing activities to assure on time regulatory submissions in accordance with project goals and timelines. Managing the projected. Visit ListedBuy for more information.
Company:
Adaptimmune
Posted:
March 27 on ListedBuy
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More About this Listing: Associate Director, Regulatory Operations-hybrid
Associate Director, Regulatory Operations-hybrid is a Executive Associate Director Job at Adaptimmune located in United States. Find other listings like Associate Director, Regulatory Operations-hybrid by searching Oodle for Executive Associate Director Jobs.
Associate Director, Regulatory Operations-hybrid is a Executive Associate Director Job at Adaptimmune located in United States. Find other listings like Associate Director, Regulatory Operations-hybrid by searching Oodle for Executive Associate Director Jobs.