Torrent Pharma Hiring for Regulatory Affairs – Assistant Manager Position

Torrent Pharma is hiring for the Assistant Manager position in their Regulatory Affairs department at the R&D Centre in Gandhinagar, Gujarat. This role offers an exciting opportunity to contribute to global and domestic regulatory activities in a dynamic work environment.

Job Details

• Position: Assistant Manager – Regulatory Affairs
• Department: Regulatory Affairs
• Location: R&D Centre, Gandhinagar, Gujarat
• Qualification: M.Sc. or M. Pharma
• Experience Required: 8 to 12 years

Key Responsibilities

Global Markets (ROW, USFDA, Europe, Brazil)

• Prepare and review BE NOC/Bio TI export applications and BE reports for submission.
• Perform e-CTD submission activities and respond to clinical queries for various markets.
• Extend BE study activities for ROW (Rest of World) markets.

Domestic Market (India)

• File BE, CT, and MMA applications under NDCT rules, 2019 using the Sugam portal.
• Submit responses to regulatory queries and ensure timely approvals for new products.
• Manage regulatory submissions for import and marketing applications, including Form-40 and Form-8.

EU Market – Pre and Post Approval

• Compile EU dossiers for Module 1, 2, and 3 with a focus on solid oral, topical, injectable, ophthalmic, and peptide formulations.
• Handle EU procedures such as DCP, MRP, and National Phase applications.
• Prepare and file post-approval variations for EU agencies.
• Utilize expertise in eCTD compilation to enhance submission quality.

Skills and Expertise

• In-depth knowledge of regulatory guidelines and compliance standards for global and domestic markets.
• Strong understanding of Module 2 and Module 5 (clinical submissions).
• Proficiency in using regulatory portals like Sugam.
• Experience with eCTD submissions and query resolution.

How to Apply

If you meet the qualifications and are passionate about regulatory affairs, send your updated CV to devalmodi@torrentpharma.com.