07 Sep
|
U Square Lifescience
|
India
07 Sep
U Square Lifescience
India
Essential Duties and Responsibilities:
Dossier preparation as per the ACTD, CTD (Module I, II, III, IV and V) & as per country specific 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.
Make PD as per product registration
Dosage - Oral solid, Liquid, Injectable, Ophthalmic, Topical
Market - ROW, Latam, African Countries
Pay: ₹18,000.00 - ₹60,000.00 per month
Advantages:
Provident Fund
Work Location: In person
📌 Executive Regulatory Affairs Makarba (India)
🏢 U Square Lifescience
📍 India