Aditi Shah Email Address

Associate Director, Global Regulatory Affairs

Otsuka in the U.S. From a family business to a global pharmaceutical business. Research and development of new pharmaceutical products and Digital Medicine. Fulfil your dreams with a career in pharma at Otsuka.

• Regulatory affairs concepts of laws, regulations, and regulatory agencies governing Pharmaceuticals, Devices, Biologics and Combination Products marketed in the US and global market. Knowledge on market clearance pathways for drugs, biologics, medical devices and combination products. • Drug discovery concept of development of small molecule and biological drugs. Discovery path through selection of targets from target selection and identification of a potential candidate to the preclinical characterization of the drug. • Created a marketing portfolio for a phase III clinical trial drug for Diabetes. • Profound knowledge of Clinical trial phases, study design, IRB requirement and recruitment. • Prepared an Informed Consent Form, IND Application. Knowledge and filing strategies of ANDA and NDA application known. • Graduate courses in Regulatory Affairs, Pharmaceutical Product management, Intellectual property, Practical Aspect of Clinical trial, Ethics and regulation in US healthcare, Drug discovery through Preclinical Development, Statistic in Clinical and translational Research, Drug development from Concept to market, Leadership and communication, Project management, Product Innovation, Marketing, Accounting and Finance.