Torrent Pharma Hiring M.Pharm, MSc Candidates in Regulatory Affairs Department

Torrent Pharma, the flagship Company of Torrent Group is one of the leading pharma companies of the Country. The Company was a pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.

Post : Assistant Manager

Experience : 08 to 12 Years
Qualification : M.Pharm./ M.Sc.
Location : R&D Centre (Gandhinagar, Gujarat)
Department : Regulatory Affairs

Job Description
Market : ROW/ Clinical
• BE NOC/Bio Tl 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