Executive Regulatory Affairs(Drug)

2 weeks ago


Panchkula, India ASTONEA LABS LTD Full time

**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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