Torrent Pharma Hiring For RA Department

Torrent Pharma Hiring For RA Department 

Position : Assistant Manager 

Department : Regulatory Affairs Department

Qualification : M. Sc./M. Pharma

Experience : 08 to 12 Years

Market: ROW/Clinical

•BE NOC/Bio TI Export application

•BE report review/e-CTD submission activity for Global markets

• Having good understanding on Module 2 and Module 5 (clinical part) submission/query response activity for

USFDA/EUROPE/BRAZIL/ROW markets.

•BE study extension activity for ROW markets

•Market: Domestic

•Application for BE/CT/MMA (CT-5, CT-4, CT-21) and Import & Marketing application (CT-18, Form-40, Form-8) to DCGI as per NDCT rules, 2019 in Sugam portal.

•Submission of query response and follow up for new product approvals.

• Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers.

•Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.

Market: EU Market - Pre and Post Approval

•Formulation Regulatory experience of various dosage form like Solid oral/Topical/Solutions/Suspension/Injectable /Ophthalmic/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

•Experience of eCTD compilation would be added advantage

Job Location: R&D Centre (Gandhinagar, Gujarat)

Interested candidates may share their CVs on devalmodi@torrentpharma.com

Torrent Pharma Hiring For RA Department