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

- Recent 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.

📌 Executive - Regulatory Affairs - EM Market (Gurugram)
🏢 SUN PHARMA
📍 Gurugram