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

Torrent Pharma, the flagship Company of Torrent Group is one of the leading pharma companies of the Country. The Company was a pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.

Post : Assistant Manager / Executive

Experience : 4 to 12 Years
Qualification : M.Pharm./ M.Sc.
Location : Gandhinagar (Gujarat)
Department : Regulatory Affairs

Job Description
For EU Market - Pre and Post Approval
• Formulation Regulatory experience of various dosage form like Solid oral / Topicals / Solutions /Suspension/ Injectables / Ophthalmics/Peptide.
• EU dossier compilation especially for Module 1,2 & 3
• Seasoned experience in handling of various EU procedure like DCP, MRP, National
• National phase handling for EU procedures.
• Post approval variation compilation and filling to various EU agencies
For US Market - Pre and Post Approval
• Formulation Regulatory experience in dosage form like Solid oral / Topicals / Solutions / Suspension/ Injectables / Ophthalmics/Peptide.
• ANDA compilation for Module 2 & 3
• Query responses and Tracking of documents
• PAS/CBE-30 and Annual report compilation and filling to agency
• Label and SPL preparation.
• Experience of eCTD compilation would be added advantage