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Torrent Pharma

8 to 12 years

Gandhinagar, Gujarat

M.Pharm, MSc

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

Company Overview: Torrent Pharma, a flagship company of the Torrent Group, is one of India’s leading pharmaceutical companies. It pioneered the concept of niche marketing in India and is a leader in therapeutic segments such as cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI), women’s healthcare (WHC), diabetology, pain management, gynecology, oncology, and anti-infectives.

Job Title: Assistant Manager
Department: Regulatory Affairs
Location: R&D Centre, Gandhinagar, Gujarat
Experience: 8 to 12 years
Qualifications: M.Pharm or M.Sc

Job Description

Responsibilities:

Market: ROW/Clinical

  • BE NOC/Bio Tl Export applications
  • BE report review and e-CTD submission activities for global markets
  • In-depth understanding of Module 2 and Module 5 (clinical) submissions/query response for USFDA, EU, Brazil, and ROW markets
  • BE study extension activities for ROW markets

Market: Domestic

  • BE/CT/MMA application submissions to DCGI (Sugam portal)
  • Submission of query responses and follow-ups for new product approvals
  • Ensure timely filing of high-quality regulatory submissions
  • Prepare, maintain, and control regulatory dossiers
  • Interaction with regulatory agencies for drug product approvals

Market: EU

  • Regulatory experience in various dosage forms: Solid oral, Topical, Solutions, Suspensions, Injectables, Ophthalmic, Peptides
  • Compilation of EU dossiers, especially for Module 1, 2, and 3
  • Experience with various EU procedures (DCP, MRP, National Phase)
  • Post-approval variation compilation and filing to EU agencies
  • Experience in eCTD compilation is an advantage

Interested candidates can send their CVs to:
Email: devalmodi@torrentpharma.com
Last Date to Apply: 25th December 2024

Torrent Pharma Hiring Regulatory Affairs Department
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