Senior Executive Regulatory Affairs

Locations --
Mumbai
Business Area/Department --
Regulatory
Contract Type --
Permanent

KEY RESPONSIBILITIES AND ACCOUNTABILITIES:

  • Timely submission of complete, right first-time, high quality applications; complete and accurate responses to Requests for Information (RFI) and effective communication of approvals
  • Varying licences in markets that allow for this procedure
  • Preparing and filing renewal applications as per renewal schedule in concerned markets.
  • Checking and reviewing product artwork for country specific regulatory compliance.
  • 100% accurate and complete recording of all regulatory submissions, correspondence with authorities and approvals and any associated logs.
  • Implementing and complying with the Company policies and procedures in effect.
  • All queries from internal and external customers are answered in accordance with SLAs.
  • Ensuring that document management system has the most current and accurate approved information for the molecule managed by the employees
  • Ensuring compliance and continuity of product supply and support to the Commercial team(s) in achieving this objective
  • Supporting the Manager/Senior Manager in management of team tasks and co-ordinate/deputise in their absence
  • Act as a buddy and train new joiners within the team on company processes and team objectives
  • Review and sign-off minor applications for self and the team (under supervision from the Manager/Senior Manager)
  • Proactively establishing Regulatory strategy, in line with related product’s activities and business needs
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