Ritu Gharat

Regulatory Affairs Manager @Tata Consultancy Services

Mumbai, IN

Currently working as a Submission Publishing ManagerThe basic profile of my job is-Superuser for Veeva vault-Supervised ticket resolution processes for content plan-related activities, ensuring efficient and timely resolution of issues while maintaining high standards of customer service- Developed Standard Operating Procedures (SOPs) and quality check plans for submissions processed in Veeva RIM Vault, ensuring accuracy and regulatory compliance- To manage client communication, support Submission delivery for MAA submissions to US UK GCC AU CA and other countries-Experience in people management and responsible for SLA KPI compliance for team-Compilation, validation and publishing of submissions and their life cycle managementEarlier worked as Clinical Publishing Specialist-Well versed with Veeva eTMF and RIM Vault-Trained on dynamic linking within Veeva RIM- Responsible to share inputs for workflow designing in Veeva and create training material and documents migration- Implement Agile practices to deliver submission

Maharashtra

S.S.C

Mumbai University

M.Sc

Specializations

M.Sc

Mitcon biopharma

Diploma