Pankaj Dhapade

Biography

-Young master candidate in pharmaceutical management having more than 8 years of experience in pharmaceutical drug regulatory affairs (formulation), formulation development & site transfers and more than 1 year of experience in regulatory affairs project management. -Experience in planning of projects, execution, monitoring & controlling and closure of the projects. -Adept in managing new applications, response to queries, post-approval changes and renewals of the drug products. -Adept in communicating with health authorities, consultants and vendors. -Regulatory assistance to the scientists during drug product development stages. -Experience in eCTD and NeeS submissions through RAMAXL, TPRA-Portal, CESP using PharmaReady software. -Visited Wockhardt, Wrexham UK for gap analysis of products in comparison with British Pharmacopoeia. -Achieved ‘Excellence at Work’ award October 2011 for managing a team.

Research Interest

Regulatory Affairs, CMC writing, Variations, Training and Development