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Thepharmadaily
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Regulatory Affairs Associate

Regulatory Affairs Associate

0 - 3 years

|

3 - 7 Lacs

Indore Madhya Pradesh India

Posted:1 day ago| Platform: Foundit logo

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Skills Required

Regulatory Compliance Clinical Trials FDA Submissions Labeling Regulations Risk Management

Work Mode

On-site

Job Type

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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