Manager - Regulatory Affairs - Pharma - South East Asia/LATAM/Middle East Region (5-15 yrs)

Key Responsibilities:

1. Regulatory submissions Emerging Market (Precisely Latin America)(South East Asia) and (Middle east) and Query Response subsequently comply with applicable regulatory requirements.

2. Compile and review all documents required in line with the relevant guidelines. Coordinate with relevant depts and prepare submissions.

3. Review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

4. Draft and review Product Information & labeling as required.

5. Prepare version-controlled CMC writeup for the respective section.

6. Track Variation filings and approvals. Maintain database.

7. Perform registration compliance reviews against quality documentation.