Regulatory Affairs Officer

5 days ago


Andheri Mumbai Maharashtra, India Sovvaka Global Pvt. Ltd. Full time

Ø Acquiring knowledge about regulatory guidance in various countries and various dosage forms and implementing them at the time of filling.

Ø Replying queries to Ministry of Health authorities of African Region.

Ø Maintaining record of registration status and re - registration.

Ø Internal Co-ordination with Mfg. Plant, R&D and QA-QC and medical team for Project execution.

Ø Should coordinate with factory for samples, working standards, document data, license related document

Ø Preparation of text matter and checking of artworks.

Ø Review and prepared all Quality documents like Specifications, protocol, Process validation, BMR

**Job Types**: Full-time, Permanent

Pay: Up to ₹400,000.00 per year

**Benefits**:

- Paid time off

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Performance bonus
- Yearly bonus

Application Question(s):

- How many dossier you have prepared in 1 month ?
- Which dosage form have you handled?

**Education**:

- Bachelor's (preferred)

**Experience**:

- ROW: 1 year (preferred)

**Location**:

- Andheri, Mumbai, Maharashtra (preferred)

Work Location: In person



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