Regulatory Affairs Executive
1 day ago
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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