Regulatory Affairs Executive

2 days ago


Sola Ahmedabad Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full time

We are hiring for _**Sr. Executive - Regulatory Affairs. **_

Qualification: B.pharm/M.pharm

Experience - 3 to 5 years only

Location - Sola, Ahmedabad

Work mode - on site

**Role & responsibilities:

- **
- Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
- Technical documents like Raw Material and finished products specification, manufacturing process,
- Product development report, stability reports, process validations preparation & review.
- Analytical method validation review as per the ICH guideline.
- Drug Master File review
- Technical query response to the various regulatory authorities.

**Market - ROW: Africa, Latin America, Eastern Europe, the Middle East, and parts of Asia country exposure is required.**

Schedule:

- Day shift

Supplemental Pay:

- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person



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