Regulatory Specialist

3 weeks ago

Bangalore Karnataka, India ScaleneWorks People Solutions Full time

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

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