Education: UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Posted Date: 15 Jul
Desired Candidate Profile
Knowledge of Medicinal Chemistry pertaining to the product development as per Global regulatory requirements.strong experience in EU/US/Canada on compilation/review,submission & approval,Knowledge about Stability/stress studies,team managemt Skills
Job Description
CTD dossier as per ICH, strong exp in EU/US/Canada on compilation/review,successful submission & approval,Clinical & preclinical Documents requirements review & compilation,Product Development Report/ Technical Transfer Document / Process Validation
Keywords: Knowledge about Medicinal Chemistry, IRA of EU / US / Canada,CTD dossier,Stability & stress studies, Dossier planning,Preclinical studies,Process Validation,Pharma /Herbal /Personal care regulatory affairs
Company Profile
The client is a leading name in the Pharmaceutical and Lifescinces industry with strong presence in the Indian and overseas market, hiring a Manager IRA with strong regulatory Affairs knowledge .