Acquired in-depth understanding and leadership skills through hands-on by working in highly dynamic flagship companies on various regulatory submissions for clinical trials (CTA), new drug applications, marketed brands and generics regulatory submissions. Good understanding of Technical Operations/Research and Drug Development/ Global or country specific regulatory requirements. Goal-oriented with demonstrated professionalism, result-driven regulatory affairs professional with around 20 years of experience of continuous advancement ...Specialties: Regulatory strategy development, IND, IMPD, NDA, MAAs, Branded products (post approval submissions), generic (National, MRP, DCP) and biologics submissions, leadership as individual contributor, team leadership/people management, technical project management in regulatory affairs, Six Sigma certification, keen to be part of any new venture...