Priya Reddy Email and Phone Number

- Leading a team of 8-10 regulatory strategists responsible for authoring CMC sections for post-approval variations.- Involved in deciding regulatory strategies during pre-submission and for post-approval changes.- Complete review of dossiers-CMC sections authored by the team before handing it over to regional counterparts for further review and submission to Health Authorities.- Responsible for Quality submissions to EU, LATAM, APAC, ANZ markets.- Review of responses to queries received from the above-mentioned health authorities.- Coordination between stake holders internal (R&D) and external counterparts across the globe to ensure smooth and timely submissions.- Formerly, Responsible for End to End submission of dossiers across geographies viz., EU, AUS, NZ, APAC, LATAM, AFME

Responsible for Submissions in EU/AUS/NZ and APAC/LATAM/MENA and other countries

EU CMC and EU Life Cycle Management and Submissions to Agency

EU submissions and Life Cycle Management