Executive / Sr. Executive - Regulatory Affairs
1 Nos.
35605
Full Time
1.0 Year(s) To 5.0 Year(s)
1.80 LPA TO 4.20 LPA
Legal & Regulatory / Company Secretary
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; M.Pharma - Pharmacy
Job Description:
- 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: Africa, Latin America, Eastern Europe, the Middle East, and parts of Asia country exposure is required
Qualification: B.Pharm or M.Pharm candidates only
Office Location: Near Divya Bhaskar Press, S G Highway, Makarba, Ahmedabad
Salary up 35 KPM negotiable depending on the experience
Further call +91-9510146364 or share resume -sangeeta@postaresume.co.in
Key Skills :
Company Profile
Company is in man---fact---ring of finished prod---cts of pharma since last 14 years
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