
Regulatory Affairs Professional
5 days ago
Job Title:
- Job Summary:
- Key Responsibilities:
- - Prepare and review SOPs, QMS documents, and other regulatory submissions.
- - Handle and execute activities related to Quality Management System (QMS).
- - Prepare and review open and closed parts of DMF, as well as annual product quality reviews.
- - Liaise with regulatory agencies and review quality agreements with customers.
- - Prepare and implement LOA and LOC.
- Requirements:
- - Experience in Regulatory Affairs in API/Pharma industry.
- - Knowledge of GMP regulations and international standards.
- - Excellent communication and analytical skills.
-
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