Regulatory Affairs Assistant

2 weeks ago

Mumbai Maharashtra, India Zieva Farm Pvt Ltd Full time

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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