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Job summary

This Position is for Executive level position for Regulatory Affairs.

Roles & Responsibilities:

  • Compile, prepare, review and submit regulatory dossiers & applications to authorities, mainly in India and emerging / ROW markets
  • Monitor and follow-up on application status directly or through liaison agents and prepare appropriate responses to queries from regulatory authorities
  • Assess the acceptability of manufacturing data, quality, preclinical & clinical documentation and compile for regulatory filing
  • Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
  • Anticipate & guide on regulatory requirements & potential obstacles throughout the product lifecycle such as manufacturing process changes and updation of specifications
  • Develop new regulatory policies, processes and SOPs and train key personnel on them
  • Coordinate on Pharmacovigilance procedures including filling of forms, compiling investigation report & reporting to authorities
  • Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met
  • Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies

Job Application Form - RA Executive (LVBRAEXEC)