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Torrent Pharmaceuticals Limited hiring for Regulatory Affairs Department

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]

Torrent Pharmaceuticals Limited hiring for Regulatory Affairs Department