SUPRAJA SEENI
Eluru
Summary
Motivated and detail-oriented regulatory affairs professional with 1.8 years of experience in global regulatory submissions, labeling compliance, and artwork reviews. Committed to contributing technical and strategic input toward the development and maintenance of global pharmaceutical products.
Overview
2
2
years of professional experience
Work History
Global Regulatory Affairs
Merck Specialties Private Limited
Bangalore
08.2023 - Current
- Maintained and updated Company Core Data Sheets (CCDS) and Reference Product Information in coordination with medical and safety teams.
- Reviewed and approved labeling to ensure timely regulatory compliance.
- Submitted regulatory data to external databases as necessary.
- Drafted and revised SOPs, Work Instructions (WIs), and internal policies.
- Contributed to the implementation of global systems, tools, and processes for development, and marketed products.
- Reviewed revised artworks, and tracked RLD labeling changes.
- Maintained databases and artwork repositories.
- Handled PRAC recommendations, and facilitated timely submissions.
- Managed patent amendments and proprietary name reviews via Veeva.
- Used Veeva Vault for inter-team document sharing, and initiated change controls as required.
- Initiated the change controls as and when required.
Education
Pharm.D -
Andhra University
08-2023
Skills
- VEEVA Vault
- Completing regulatory documents
- Regulatory research
- Labeling approval
- Regulatory compliance
- Cross-functional collaboration
- Agile response to change
- Skilled in computer applications
- MS Word
- Excel
- PowerPoint
- Verbal communication
- Written communication
Timeline
Global Regulatory Affairs
Merck Specialties Private Limited
08.2023 - Current
Pharm.D -
Andhra University
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