Saikumar Bejju
Regulatory Affairs Specialist with expertise in Veeva Vault and eCTD |submission Mangement| EU|US| Row Markets| Project Mangement |CMC Activities| Post Approvals | Renewals| Labelling| Art work Mangement.
- Role
- Senior Regulatory Affairs Associate at Parexel
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Saikumar Bejju
As a Senior Regulatory Affairs Associate at Parexel, I have over three years of…
Experience
Senior Regulatory Affairs Associate
Jul 2021 — Present · Telangana, IN
In my role as a Senior Regulatory Affairs Associate at Parexel, I have extensive experience in regulatory publishing and managing variation filings post-approvals.I handled and supported renewal and variation submissions, conducted KOM meetings for renewal projects, and coordinated with global teams for labelling changes. I also participated in SEP CC meetings and finalized artwork changes, ensuring compliance with country requirements and facilitating translations when necessary.
Education
Jawaharlal Nehru Technological University
Bachelor's degree
JNTUH College of Engineering Hyderabad
Master in pharmacy, pharmaceutics
2013 — 2015
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