Sameer
Regulatory Affairs Executive at Micro Labs Limited, Bengaluru Karnataka. |CMC| |US| |eCTD|
- Role
- Regulatory Affairs Executive at Micro Labs Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sameer
My career objective is to become a part of a dynamic team and an organization where I can…
Experience
Regulatory Affairs Executive
Jan 2025 — Present · Bengaluru, IN
Prepared product dossiers and technical documentation for US FDA oral submissions, ensuring accuracy and compliance with FDA requirements.• Monitored regulatory updates from FDA and other authorities to maintain compliance.• Provided regulatory guidance to product development teams on FDA obligations (pre- and post-market).• Used PharmaReady for eCTD submissions.• Coordinated with R&D, Quality, Manufacturing, and Clinical teams to provide accurate responses to FDA queries within strict timelines.
Education
Sri Adichunchanagiri College of Pharmacy
Master's in pharmacy , PHARMACEUTICS
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