Responsible for handling Regulatory Affairs for India and India hub (Sri Lanka, Bangladesh, Nepal, Bhutan and Maldives)

RA and QA Lead responsible for Subcontinent region

• Review all the study related documents including Protocol, Investigator’s Brochure and Investigational Medicinal Product Dossier for Global Clinical Trials.• Review the available non clinical and clinical data as per the regulatory requirements.• Independence in compiling the Clinical Trial Application dossier and related application for New Drugs, Medical Devices and Biologicals in India.• Preparation of Clinical Trial Application and subsequent submissions in Asia pacific countries namely Hong Kong, Malaysia, Philippines, South Korea, Singapore and Taiwan.• Preparation of Marketing Authorization and Product Registration applications for New Drugs and Medical Devices.• Review labels of the study drug as per the regulatory requirement.• Prepare miscellaneous applications and notifications i.e. Protocol Amendment application, Import license revalidation, Export NOC application, Inclusion/Exclusion of site, Updated Investigator’s Undertaking, Updated Investigator’s Brochure, Annual Study Status Report, Clinical Study Report etc. for India, Hong Kong, Malaysia, Philippines, South Korea, Singapore and Taiwan.• Develop relationship and networking at DCGI Office to strengthen follow up and timely approval.• Responsible for CTRI {Clinical Trial Registration (India)} activities including registration and updation of trials.• Understanding and implementing Subject Expert Committee (SEC) related submissions and follow ups.• Attend calls with the sponsor for study planning and discussion.

Review all the study related documents including Protocol, Investigator’s Brochure and Investigational Medicinal Product Dossier.Review the available non clinical and clinical data as per the regulatory requirements.Independence in compiling the clinical trial application dossier and related application.Review labels of the study drug as per the regulatory requirement.Prepare miscellaneous applications and notifications i.e. SAE notification, CIOMS & MEDWATCH notification, Protocol Amendment application, Import license revalidation, Export NOC application, Inclusion/Exclusion of site, Updated Investigator’s Undertaking, Updated Investigator’s Brochure, Annual Study Status Report, Clinical Study Report etc.Develop relationship and networking at DCGI Office to strengthen follow up and timely approval.Complete control over CTRI {Clinical Trial Registration (India)} activities including registration and aupdation of trials.Understanding and implementing New Drug Advisory Committee (NDAC) related submissions and follow ups.Attend weekly calls with the sponsor and update sponsor regarding the status of their application at DCGI office.