Sai Prathyusha

About Sai Prathyusha

Global Regulatory Affairs Leader with 7 years of experience driving regulatory strategy…

Experience

1. Global Inn Regulatory Lead - Scientific Affairs Strategic Coordination Eu

   Opella

   Jun 2024 — Present

   Ensures the regulatory strategy is in place for different pre- and post-approval activities, requiring CMC, medical and non-clinical input, depending on country requirements and/or company ambitionProvide scientific contribution to single documents such as RMP, PSURs, Addendum to Clinical and Non-Clinical Overview, Core labelling documentation (Company Core Data Sheets and Core Safety Profiles).As a regulatory portfolio owner of established products, is accountable for maintenance of the existing portfolio with a worldwide scope, for processes starting from preparation to the submission/dispatch to affiliates on time.Accountable for the coordination of the preparation and on-time delivery of compliant submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions, either for new Marketing Authorizations or post-approval eventsManages the interactions as appropriate with the Affiliates to ensure compliance with local requirements, provides the advice and searches for synergies across submissions.Works in compliance with Sanofi Quality Documents (QDs) while looking for opportunities to streamline processes in the future.Proactively identifies and communicates to higher management all potential risks and options for issue resolution.(maintenance issues, submissions)Monitors and contributes to Veeva compliance for portfolioActively and proactively contributes to provide regulatory insights, to help drive and shape the strategy for the products in scope.Works collaboratively within cross functional teams to create project plans that identify opportunities, regulatory risks and mitigation strategiesContributes to close collaboration with medical, PV, labelling, CMC, Reg Ops and business teams in the revision and validation of the documentation within the assigned portfolioSupports Commercial teams in the launch activitiesMonitors regulatory intelligence tools and shares the learnings/alerts within Team

Education

• Indira Gandhi National Open University

  Bachelor of Arts (Hons.) Psychology

  2020 — 2022

• Manipal College of Pharmaceutical Sciences, Manipal

  Master's degree

  2017 — 2019

• MLR Institute of Pharmacy

  Bachelor of Pharmacy - BPharm

  2013 — 2017