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Associate Director, Regulatory Affairs London United Kingdom,  

Posted on : 08 March 2017

Project Description

ObjectivesCollaborates to define, develop and lead global and/or regional strategies to maximize regulatory success towards achievement of program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides 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.Provide regulatory expertise for multiple projects or one complex development project and / or marketed product(s) of responsibility.Manages and trains direct reports and / or mentors team members, if required, to support scope of project work.May be called upon to act as deputy to the Global Regulatory Lead, therapeutic area head and/ or Region regulatory head, and/or Marketed Products Head, attending internal leadership 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 to future business requirements.Primary EMA 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 globally or for own region and represents as needed at project team and ensures global and/or regional regulatory lifecycle management strategy and submission planning written and executed according to plan  or oversees if delegated to staff and/ or vendor.For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe).Identifies relevant global /regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility.


London England United Kingdom

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