Regulatory Specialist - Submission Coordinator - Secondment
Regulatory Specialist - Submission Coordinator - Secondment
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Job Description
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 site registrations/renewals/variations label harmonization periodic benefit risk evaluation reports (PBRER) submissions etc)
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
Basic Qualifications:
Degree in a biological healthcare or scientific discipline or Extensive experience within the drug development environment
Awareness of the pharmaceutical industry drug development environment and R&D processes and objectives.
Awareness of Regulatory Affairs responsibilities from pre-IND through Phases
I-IV
Ability to effectively interact with line and middle management staff and external contacts on a functional and strategic level in a matrix environment.
Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Ability to interpret regulations
Preferred qualifications:
Good written and verbal communication skills and ability to present information in a clear and concise manner
Excellent organizational skills attention to detail and commitment to deliver high quality output even under pressures sometimes demanded by regulatory deadlines.
Ability to work flexibility in large teams
Remote Work :
No
Employment Type
Full Time
