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Senior Manager, Regulatory Affairs, Oncology London United Kingdom,  

Posted on : 08 March 2017

Project Description

ObjectiveProvides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.Provides a regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management.As Regional Lead, may be called upon to act as deputy to the Global Regulatory lead, attending internal team meetings, as appropriate.Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning.Primary contact with health authorities for project(s)/products of responsibility in regions of responsibility, or can delegate to staff and/or vendor with oversight. Informs the business.AccountabilitiesLeads the regulatory working team


London England United Kingdom

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