Company Overview: Torrent Pharma, a flagship company of the Torrent Group, is a leading player in the Indian pharmaceutical sector. Renowned for pioneering niche marketing, Torrent Pharma excels in therapeutic segments such as cardiovascular (CV), central nervous system (CNS), gastrointestinal (GI), and women’s healthcare (WHC). The company also has a strong presence in diabetology, pain management, gynecology, oncology, and anti-infective markets.

Position: Assistant Manager / Executive, Regulatory Affairs

Location: Gandhinagar, Gujarat
Experience: 4 to 12 Years
Qualification: M.Pharm / M.Sc.

Key Responsibilities:

For EU Market – Pre and Post Approval:

• Regulatory experience in various dosage forms: solid oral, topicals, solutions, suspensions, injectables, ophthalmics, and peptides.
• EU dossier compilation, particularly for Modules 1, 2, and 3.
• Proficient in handling EU procedures such as DCP, MRP, and national phase handling.
• Post-approval variation compilation and submissions to various EU agencies.

For US Market – Pre and Post Approval:

• Regulatory experience in dosage forms: solid oral, topicals, solutions, suspensions, injectables, ophthalmics, and peptides.
• ANDA compilation for Modules 2 and 3.
• Query responses and document tracking.
• Compilation and filing of PAS/CBE-30 and annual reports to the agency.
• Preparation of labels and SPL; experience in eCTD compilation is an added advantage.

How to Apply: Interested candidates are invited to share their CVs via email at devalmodi@torrentpharma.com by 25th October 2024.