Prima Lewis
Regulatory Affairs Professional | Dossier Compilation | eCTD Publishing | Drug and Medical Device Renewals | Labeling & Compliance
- Role
- Senior Regulatory Affairs Executive at Naari Pharma Pvt Ltd
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Prima Lewis
Regulatory Affairs professional specializing in dossier compilation, eCTD publishing, and…
Experience
Senior Regulatory Affairs Executive
Jun 2025 — Present · Bengaluru, IN
Hands-on experience in CMC dossiers, renewals & post-approval changes for EU, UK & ASEAN • Knowledge of EU & UK regulatory procedures (DCP, MRP, NP, IRP) • Skilled in drafting SPCs & PILs as per QRD templates • Experienced in responding to health authority queries on time • Collaborated with cross-functional teams for regulatory submissions • Strong attention to scientific & linguistic detail in documentation
Education
Nitte University
Master's degree
2020 — 2022
M. S. RAMAIAH UNIVERSITY OF APPLIED SCIENCES
Bachelor of Pharmacy - BPharm
2014 — 2018
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