17 years of experience across all phases of drug product development and post- marketing.Expert in developing CMC regulatory strategies ensuring business goals, while maintaining regulatory compliance.A results oriented Regulatory affairs professional skilled in submission of high quality ANDAs to USFDA for Orals, Topical/TDS. My focus area is Chemistry Manufacturing Controls (CMC). I had also acquired experience in pharmaceutical manufacturing and quality assurance of solid orals.Specialities: ANDA submission, Query responses, Post approval submissions for Speciality products (Topical/TDS), Product life cycle management, Project evaluation and GAP analysis, Document management.I am a continuous learner, adaptive to changes and looking for logical ways to do the things to succeed.