Torrent Pharma Hiring For RA Department
Department : Regulatory Affairs
Position : Assistant Manager/Executive
Qualification : M.Pharm./ M.Sc.
Experience : 4 to 12 Years
Location : Gandhinagar (Gujarat)
Profile & Exposure:
1) For EU Market - Pre and Post Approval
•Formulation Regulatory experience of various dosage form like Solid oral/Topicals/Solutions/Suspension/ Injectables/Ophthalmics/Peptide.
•EU dossier compilation especially for Module 1, 2 & 3
•Seasoned experience in handling of various EU procedure like DCP, MRP, National
•National phase handling for EU procedures.
•Post approval variation compilation and filling to various EU agencies
2) For US Market - Pre and Post Approval
•Formulation Regulatory experience in dosage form like Solid oral/Topicals/Solutions / Suspension/Injectables /Ophthalmics/Peptide.
•ANDA compilation for Module 2 & 3
•Query responses and Tracking of documents
•PAS/CBE-30 and Annual report compilation and filling to agency
•Label and SPL preparation.
Experience of eCTD compilation would be added advantage
Interested Candidates May Share Their CVs On
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