Corporate Senior Management position directly reporting to CEO and Managing Director of Sun Pharma.Responsible for reviewing and certifying all pre-submission documents intended for regulatory filing to US FDA in a closed electronic system. Successfully completed review and certification of nearly 40 ANDA/NDA in timely manner for filing to US FDA by regulatory team of the Sun Pharma. Reviewed and certified nearly 3000 application such as Annual Reports, Deficiencies, DMF's and clinical reports as per extensive audit check list approved by FDA Recommend initiation of investigations/Deviations to respective stake holders based on out come of Office of Data Reliability(ODR) audit findings of pre-submission documentsTraining and educating the staff based on audit findings to minimize the errors in futureRecommend the Senior management to discipline the employee violating the cGMPClosely monitor the 'Disclosure Program' and investigate. Also recommend corrective and preventive actions to respective stake holders. Inform FDA in writing the out come of investigation as well as any disciplinary action(s) within the preview of Consent Decree Present to the board members any serious violation of cGMP in routine board meetings

Corporate VP position and directly reporting to Managing Director and CEO of the company with office located at all manufacturing sites currently exporting the Drug Products & API to US market.

Responsible for establishing policy, developing procedures, monitoring and directing all Quality compliance for in-house as well as contract manufacturing/testing sites. Daiichi Sankyo(Ranbaxy) North America, Canada and Latin America was employing >250 professionals in the quality organization.

During this period Ranbaxy expanded the North America operation by expanding the manufacturing capabilities at New Brunswick and NY. Also entered into Canadian market.

Revamped the entire quality system of two solid dosage manufacturing facilities & expanded the Quality Organization. Filed and successfully launched large number of ANDA/NDA including fifteen first to file applications and supported the business to launch the new products on day one of getting Agency approval

Highly respected Public Testing Laboratory approved by local Drug Authority, EPA Agency and Indian Standards. Highly respected Public Testing Laboratory engaged in testing Pharmaceuticals, Raw Materials, Pesticides, Insecticides, Dyes & intermediates, Food products & edible oils with staff of over 90 employees.