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Regulatory Affairs Associate
ConfidentialChennai9 days ago
Job descriptionPrepare, 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.
Skills Required
Regulatory Compliance, Clinical Trials, Risk Management
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Associate Regulatory • Chennai