EXECUTIVE / SR. EXECUTIVE - REGULATORY AFFAIRS
No of Position: Two
Designation: Executive / Sr. Executive - Regulatory Affairs
Experience: B.Pharm/M.Pharm with minimum experience of 3 to 5 years
Company: Pharmaceutical Company
Salary: Depend on candidates experience & Industry Standard
Job Profile:
- 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.
Dosage Oral solid, Liquid, Injectable, Ophthalmic, Topical
Market ROW, Latam, African Countries
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