Drugs Regulatory Affairs Officer

2 weeks ago


Delhi, India Bo International Full time

Job description

Roles and Responsibilities
- To manage new registration / re-registration / query responses/variation filings for abroad markets.
- Ensuring that quality standards are met and submissions of Dossiers meet strict deadlines.
- Review labelling and labels for compliance with regulatory requirements.
- Review technical documents like BMR, Process validation, Stability Data,
- Artworks for Dossier Preparation.
- Working on pre & post registration of dossier registration.
- Make technical file for registered dossier.
- Work on life cycle management for compilation and record for all regulatory documents.
- To get acquainted with SOPs of manufacturing department, QA and Regulatory department
- Must have their own 2 wheeler or bike for travelling
- Must live near North Delhi

**Salary**: ₹15,000.00 - ₹25,000.00 per month

**Benefits**:

- Flexible schedule
- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Delhi, Delhi: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)
- Health insurance



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