Regulatory Affairs Associate

3 weeks ago


Chennai, Tamil Nadu, India Thepharmadaily Full time
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.
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