Executive Regulatory Affairs(Drug)
2 weeks ago
**Full job description**
- Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats.
- Filing annual updates and amendments to various regions of submitted DMFs.
- Handling queries obtained from different regulatory agencies and customers.
- Generation of documents from R&D, Production, QC and QA of newly developed API’s.
- Responsible for record keeping and to ensure correctness of records pertaining to department.
- Responsible for all type of computer work and follow-ups.
- Carrying out the initial assessment of Vendor Questionnaire and relevant documents.
- **Desirable**: Minimum 03 to 05 years working experience
- B. Pharma/M. Pharma
**Job Types**: Full-time, Permanent
**Salary**: ₹20,000.00 - ₹45,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Morning shift
Supplemental pay types:
- Yearly bonus
**Experience**:
- total work: 3 years (required)
Work Location: In person
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