Executive - Regulatory Affairs - EM Market

Job Summary

Regulatory submission of new products, variations, response to queries, Life cycle management for WHO & Sub Sahara Africa markets through preparation of quality dossiers enabling timely approvals.

Area Of Responsibility

Area Of Responsibility

• New Submissions
• Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
• Review documents (Development report, scale up report, specification, stability protocol), artworks etc.
  
  

before initiation of Exhibit batches for adequacy.

• Approval:
  
  

Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

• Lifecycle management for drug formulations:
• Prepare and review variations as per the country requirements to support approval of changes such as API
  
  

vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.

• Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
• Regulatory compliance:
• Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the
  
  

same based on queries and variations.

• Ensure reposition of comprehensive product information into central repository
• Review regulatory filing impact of variations, change controls, etc.