Submission Lead
Submission Lead
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Job Description
his role will provide YOU the opportunity to lead key activities to progress YOUR career these responsibilities include some of the following
Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices
May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals label harmonisation periodic benefit risk evaluation reports (PBRER) submissions etc)
May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
May be the primary contact for the GRL maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets
May be required to lead or participate to process improvement initiatives
May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL
Remote Work :
No
Employment Type
Full Time
