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Associate Director, Global Regulatory Affairs - CMC (hybrid)
Location:
Abingdon
Description:
Adaptimmune is a clinical-stage biomedical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. 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. We are seeking a highly motivated and experienced individual for an Associate Director position in global Regulatory Affairs CMC. This position will provide CMC regulatory leadership and act as the point of contact on cross-function teams to support the strategy and development of our T cell therapies for the treatment of cancer. Key Responsibilities Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products. Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies. Plans, executes, and manages regulatory CMC submissions including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, responses to queries. Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments) Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions. Evaluates. Visit ListedBuy for more information.
Company:
Adaptimmune
Posted:
January 20 on ListedBuy
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More About this Listing: Associate Director, Global Regulatory Affairs - CMC (hybrid)
Associate Director, Global Regulatory Affairs - CMC (hybrid) is a Executive Associate Director Job at Adaptimmune located in United States. Find other listings like Associate Director, Global Regulatory Affairs - CMC (hybrid) by searching Oodle for Executive Associate Director Jobs.
Associate Director, Global Regulatory Affairs - CMC (hybrid) is a Executive Associate Director Job at Adaptimmune located in United States. Find other listings like Associate Director, Global Regulatory Affairs - CMC (hybrid) by searching Oodle for Executive Associate Director Jobs.