Regulatory Affairs Officer

2 weeks ago

Chandigarh, India Aishwarya Healthcare Full time

**JOB RESPONSIBILITIES FOR DRA OFFICER**

1. Dossier writing, compilation and evaluation of dossiers as per the guidelines of various countries in CTD/ACTD and Regional format.

2. Responsible for dossier preparation/compilation & submission of assigned dossiers and maintaining data base.

3. Handling queries received by MOH/Consultant and respond the queries on given timelines for ROW.

4. Review of compiled dossiers by sub-ordinate for minimizing the deficiency and to ensure the quality and accuracy of the dossiers.

5. Responsible for coordination with all manufacturing sites for procuring data/information for regulatory purpose.

6. Evaluation of the technical documents which are provided by all manufacturing sites and implementing the documents as per countries guideline and customer requirement.

7. Responsible for the departmental urgencies assigned by the reporting head.

8. Responsible for overall tracking management system of ROW.

**Experience**

3-4 years

**Department**

DRA

**Designation**

Sr. Officer

**Qualification**

M. Pharm/B. Pharm

**Salary**: ₹300,000.00 - ₹400,000.00 per year

**Benefits**:

- Flexible schedule
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Overtime pay
- Yearly bonus

Ability to commute/relocate:

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

**Experience**:

- total work: 1 year (preferred)

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