18 Aug
|
iSHR for IT u0026 Surveillance
|
India
18 Aug
iSHR for IT u0026 Surveillance
India
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
📌 Executive / Sr Executive Ahmedabad (India)
🏢 iSHR for IT u0026 Surveillance
📍 India