Associate Director

Clinical Research professional with twenty two years of experience in Indian multinational pharmaceutical companies. Robust background in bioanalytics, pharmacokinetics and biopharmaceutics. Strong scientific research capabilities and business acumen that drive effective laboratory operations and project management. Served as a proactive leader and team collaborator, motivated staff and established a cohesive environment focused on accountability. Leading group of scientists to operate LCMSMS and HPLCs for cost effective bioanalytical method development, validation and clinical sample analysis to support organization’s ANDA/NDA program. Proven abilities in training, mentoring and motivating team. Well versed with ICH GCP, clinical study Protocol, Human volunteer management, ICF, Ethic committee, CRF, scientific report preparation etc. Successfully leading team to host various regulatory inspections including US FDA, UK MHRA, DCGI etc. Extensive experience with compliance of US FDA, EMEA ,UK MHRA,ICH GCP, GLP , 21CFR Part 11 guidelines. Possess vast experience in auditing national & international CROs for regulatory compliance and assessing project handling capabilities for outsourcing.