Sruthi Bandaripeddinti
Cambridge
Summary
PharmD and MS in Regulatory Affairs graduate with a strong foundation in clinical and regulatory environments. Over two years of experience preparing regulatory submissions, collaborating with healthcare professionals, and managing cross-functional projects. Adept at communicating scientific data, supporting product life cycle, and ensuring compliance. Passionate about bridging science and patient care, with a growing interest in therapeutic and commercial roles.
Overview
1
1
year of professional experience
Work History
Regulatory Affairs Executive
MSN Laboratories
01.2021 - 06.2022
- Led the preparation and submission of five CTD-format drug applications within one year, resulting in 100% approvals and faster product launches by three months.
- Reviewed and supported CMC change controls for two manufacturing sites to ensure regulatory compliance.
- Collaborated with cross-functional teams to develop and approve artwork and labeling based on regional guidelines.
- Managed end-to-end dossier submissions in both CTD and Non-CTD formats for the Africa Region, ensuring timely and accurate filings.
- Handled post-approval variations and renewals, maintaining product compliance throughout the lifecycle.
- Monitored regulatory updates and provided clear impact assessments to internal teams.
- Drafted and submitted responses to regulatory queries, supporting product registrations and approvals.
Education
MS - Regulatory Affairs
Northeastern University
Boston, MA07.2024
Skills
- Regulatory Strategy & Submissions
- CMC & Compliance Documentation
- Scientific & Clinical Communication
- Cross-functional Collaboration
- Product Lifecycle Support
- CRM Familiarity (Salesforce, Veeva – basic exposure)
Timeline
Regulatory Affairs Executive
MSN Laboratories
01.2021 - 06.2022
MS - Regulatory Affairs
Northeastern University
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