Regulatory Affairs Assistant
1 week ago
Knowledge of ICH guidelines, CTD dossiers.
- Assist in preparing and compiling necessary documents for regulatory submissions.
- Coordination with manufacturer for collecting documents for preparation of dossier, review of dossier and submission to respective regulatory authority
- Coordinate with the manufacturer to gather necessary information for submission processes.
- Follow-up with manufacturing site for register sample, working standard & impurity requirement for lab analysis.
- To prepare monthly regulatory status report and status of new registration/Re-registration/post approval changes.
- Review of artwork and pack insert as per rules laid by respective regulatory authority.
- Maintain accurate and up-to-date regulatory documentation
- B. Pharm or M. Pharm with at least 2 of Experience working in reputed Pharma Company.
- Deep experience from pharmaceutical industry from a regulatory affairs perspective (Knowledge in Quality Assurance preferable)
- Fluent in oral and written English
**Job Types**: Full-time, Permanent
Pay: ₹20,000.00 - ₹30,000.00 per month
**Benefits**:
- Food provided
- Health insurance
Schedule:
- Morning shift
Supplemental Pay:
- Yearly bonus
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 5 years (preferred)
**Language**:
- English (preferred)
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