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Mumbai Area, India India

Senior Manager at Mylan Laboratories Limited

Medical / Health Care / Pharmaceuticals

A tenacious result driven regulatory affairs professional with over 10 years experience in Regulatory submissions primarily for Europe currently associated with Mylan Laboratories Ltd., India as Manager Regulatory Affairs. Current profile allows me work as project frontier for new and life cycle submission which involves direct coordination with Regulatory Agencies and EU based team members. Regulatory submission expertise includes EU MA application via National/MRP/DCP procedures, Variation and extensions applications, Amendments/supplements with in-depth understanding of Solid dosage forms. Leading a team of 7 competent Executives and Sr. Executives levels and look towards various fil...