THThepharmadaily
Regulatory Affairs Associate
Indore ₹3-7 LPA Posted 13 Aug 2025
FULL TIME
Clinical Trials
Regulatory Compliance
Risk Management
Job Description
- Prepare, review, and submit amendments and supplements for the assigned products.
- Prepare summary documents for regulatory submission.
- Prepare, review, and submit responses to the Agency s queries for the assigned products.
- Compile and submit Global Annual Reports.
- Review stability protocols and reports, analytical method validation protocols, and reports.
- Review raw material, packaging material, finished product specifications, finished product stability specifications, and testing procedures.
- Review batch records.
- Review Process Validation Protocol, hold time study protocols, and reports.
- Review Product Development Report.
- Review executed documents, including executed BMR, Certificate of Analysis, to ensure compliance with regulatory requirements.