Executive - Regulatory Affairs - EM Market

Area Of Responsibility 

1. New submissions: 

a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. 

b. Review documents (Development report, scale up report, specification, stability protocol), artworks etc. 

before initiation of Exhibit batches for adequacy. 

2. Approval: 

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

3. Lifecycle management for drug formulations: 

a. 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. 

b. Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies 

4. Regulatory compliance: 

a. Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the 

same based on queries and variations. 

b. Ensure reposition of comprehensive product information into central repository 

C. Review regulatory filing impact of variations, change controls, etc.