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