Regulatory Affairs Executive
3 weeks ago
To review technical documents received from respective manufacturing facility and prepare regulatory documentation for submission to regulatory agencies.
Coordination of dossier preparations and submissions for emerging markets according to the plans (new registration and maintenance) and monitoring dossiers up to implementation
Coordinate with CQA department for technical documents and to review the documents for accuracy as per Country specific requirement.
Prepare accurate and timely responses to queries received from regulatory agencies
Timely compile materials for license renewals, updates and registrations.
Maintain regulatory files, establish and maintain system for tracking of documents submitted to agencies.
Review labeling and labels for compliance with regulatory requirements.
Maintain current information of international regulation, guidance and Standards applicable to company products.
Routine update of regulatory status
To approve the product artwork for registration.
Communicate and follow up with agent for progress of registration submission.
Maintain record for the Dossier and sample submission.
Maintaining & updating country wise registration status and arranging for renewal.
Working Days
- Monday to Friday
Office Timings
- 9am-6pm
Pay: ₹300,000.00 - ₹600,000.00 per year
**Benefits**:
- Paid sick time
- Provident Fund
Schedule:
- Day shift
**Experience**:
- total work: 3 years (preferred)
Work Location: In person
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