Executive / Sr Executive Ahmedabad

Executive / Sr Executive Ahmedabad

14 Aug
|
iSHR for IT & Surveillance
|
Ahmedabad

14 Aug

iSHR for IT & Surveillance

Ahmedabad

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
🏢 iSHR for IT & Surveillance
📍 Ahmedabad

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