Executive / Sr. Executive (Ahmedabad)

Executive / Sr. Executive (Ahmedabad)

13 Aug
|
iSHR for IT & Surveillance
|
Ahmedabad

13 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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