Torrent Pharma Hiring for Regulatory Affairs – Assistant Manager Position

Torrent Pharmaceuticals Limited; Gandhinagar; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Torrent Pharmaceuticals Limited in Gandhinagar, Gujarat, seeks an experienced Assistant Manager for Regulatory Affairs to join the R&D Centre. The role centers on managing global and domestic regulatory submissions and ensuring regulatory compliance across markets.

You will work on BE/NOC exports, eCTD submissions, and EU dossier activities, requiring 8–12 years of experience and a MSc or M.Pharm degree. The position offers growth in a dynamic regulatory environment.

Qualifications

• 8–12 years of regulatory affairs experience.
• MSc or M.Pharm degree required.
• Knowledge of global regulatory guidelines and submissions.

Responsibilities

• Prepare and review BE NOC/Bio TI export applications and BE reports for submission.
• Perform eCTD submission activities and respond to clinical queries for various markets.
• File BE, CT, and MMA applications under NDCT rules using the Sugam portal.
• Compile EU dossiers for Module 1–3 and manage DCP/MRP/National Phase and post‑approval variations.

Skills

Regulatory strategy

eCTD submissions

Sugam portal

Regulatory intelligence

Query resolution

Education

MSc

M.Pharm

Tools

Sugam portal

eCTD tooling

Job description

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: MSc. 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.