Apply Now

Title: Executive - Regulatory Affairs - EM Market

Date: Sep 18, 2026
Location: Gurgaon - R&D;
Company: Sun Pharmaceutical Industries Ltd

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 Responsibility1. Current 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 stakeholders 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.

Apply Now

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