Alekya V
Master’s in Pharmaceutical Regulatory AffairsManipal College of pharmaceutical sciences,MAHE(2024-2026)
- Role
- Regulatory Affairs Intern at Onesource
- Location
- Brahmapur, OD, IN
- LinkedIn followers
- 500 followers
About Alekya V
I am currently pursuing my M.Pharm in Regulatory Affairs, with a focus on understanding global regulatory frameworks like FDA, EMA, and ICH. I’m passionate about solving regulatory challenges and ensuring product safety and compliance. My goal is to help bring innovative and effective pharmaceutical products to market by navigating complex regulatory pathways.
Experience
Regulatory Affairs Intern
Oct 2025 — Present · Bengaluru, IN
Prepared and supported U.S. FDA Annual Reports, ensuring accuracy, and regulatory compliance. Reviewed Periodic Adverse Drug Event Reports (PADERs) for data consistency and adherence to regulatory requirements.Drafted and reviewed regulatory cover letters and completed FDA and EU submission forms for regulatory packages. Supported electronic regulatory submissions, ensuring correct document sequencing and placement. Reviewed stability data and maintained Excel-based regulatory tracking sheets to support product lifecycle activities.
Education
Manipal college of pharmaceutical sciences
Masters, Pharmaceutical regulatory affairs and management
Raghu College Of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy
Raghu College Of Pharmacy
Bachelor's Degree
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