Company- Protech Biosystems Pvt. Ltd.
Job Title- Compiler (Drug Regulatory Affairs)
Location- Gurgaon (Haryana)
JOB Profile
*Dossier Preparation:
Prepare regulatory dossiers in ACTD, CTD, and country-specific formats, ensuring compliance with respective regulatory authority requirements.
*Drug Master File (DMF) Review:
Review the Drug Master File in accordance with applicable regulatory guidelines and country-specific demands.
*Regulatory Documentation:
Handle documentation processes for obtaining product permissions, Certificates of Pharmaceutical Product (COPP), Free Sale Certificates (FSC), and No Objection Certificates (NOC).
*Query Resolution:
Respond promptly and effectively to queries received from MOH consultants, ensuring all concerns are addressed within specified deadlines.
*Technical Document Review:
Review QA, QC, and production-related technical documents for accuracy, completeness, and regulatory compliance.
*Cross-Department Coordination:
Coordinate with QA, QC, and other departments to gather the required documentation for effective dossier preparation and compilation.
*Artwork Review:
Review and approve product artwork to ensure it meets all regulatory and country-specific labeling and packaging standards.
Qualification
1. B. Pharma/ BSC
Experience
1. 2-3 years of experience
Salary
1. As per candidate skills.
Interested candidates should share their CV on
WhatsApp- 9560226200
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