Torrent Pharmaceuticals Limited is a leading Indian pharmaceutical company headquartered in Ahmedabad, Gujarat. It is known for its wide range of generic and specialty medicines.
Job Posting: Regulatory Affairs Assistant Manager/Executive
Company: Torrent Pharma
Location: Gandhinagar, Gujarat, India
Position: Assistant Manager/Executive
Department: Regulatory Affairs
Qualification: M.Pharm./M.Sc.
Experience: 4 to 12 years
Profile & Exposure:
For EU Market – Pre and Post Approval
•Formulation Regulatory experience in various dosage forms like Solid oral / Topicals / Solutions/Suspension/Injectables / Ophthalmics/Peptide.
•EU dossier compilation, especially for Module 1, 2 & 3.
•Seasoned experience in handling various EU procedures like DCP, MRP, National.
•National phase handling for EU procedures.
•Post-approval variation compilation and filling to various EU agencies.
For US Market – Pre and Post Approval
•Formulation Regulatory experience in dosage forms 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 the agency.
•Label and SPL preparation.
•Experience of eCTD compilation would be an added advantage.
Interested candidates may share their CVs on:
[email protected]
