Executive - Regulatory Affairs
U Square Lifescience · Ahmedabad · onsite · Posted 48d ago
Undisclosed3–6 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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 All Dosages Forms i.e., Tablet, Capsule, Liquid Injection, Dry Powder Injection, Lyophilized Injection, Power Sachet, Syrup, Suspension, Cream, Gel & Ointment etc.
Market ROW, LATAM, African Countries
Sourced from naukri
Skills
LatamRow MarketRegulatory AffairsDossier PreparationActdCTD