JB-1602 - Senior Executive - Regulatory Affairs

Job Description

1. Review analytical methods for APIs and finished pharmaceutical products.
   

2. Review analytical method validation protocols and validation study reports.
   

3. Review API and finished product specifications, limits, and acceptance criteria.
   

4. Review stability study data and shelf-life justifications in line with ICH guidelines.
   

5. Review DMF analytical sections and critical API quality attributes for compliance.
   

6. Verify analytical compliance for BE study sample testing and reporting activities.
   

7. Identify analytical documentation gaps impacting regulatory acceptability.
   

8. Support preparation of analytical-related responses to regulatory authority queries.
   

9. Verify alignment of analytical data with CTD Module 3 structure and expectations.
   

10. Maintain accuracy, traceability, version control, and integrity of analytical records. 
    

1. Bachelor’s or Master’s degree in Pharmacy is mandatory.
   

2. Minimum three years experience in QC or analytical validation roles.
   

3. Hands-on experience reviewing analytical method validation documentation.
   

4. Should have good communication skills.
   

5. Strong analytical data interpretation and technical documentation review skills.
   

1. Remote working option with defined review responsibilities.
   

2. Flexible working hours aligned to dossier and submission timelines.
   

3. High technical ownership without laboratory or shop-floor operations.