Aishwarya Patil
Regulatory Affairs, CMC Post-approval Variations at GSK || Veeva Vault RIM ||M.Pharmacy, Pharmaceutical Quality Assurance || DYPIPSR, Pune
- Role
- Apprentice Regulatory Affairs at GSK
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Aishwarya Patil
Regulatory Affairs (CMC) professional with experience in post-approval variations, Module 3 updates, lifecycle management, and market specific requirements. I have handled 4 submissions and responded to 4 HAQs across EU, US, Canada, and RoW markets.Skilled in managing Type IA/IAIN, IB, and Type II variations, supporting MRP, DCP, and National Procedures, and working with Veeva Vault RIM. I also hold a experience of working on license certification for EU regulatory procedures, strengthening my understanding of EU submission pathways and compliance requirements.Academically strong with university ranks in B.Pharm and M.Pharm, achievements in national/international poster presentations, and a published research article. Motivated, detail-oriented, and focused on enhancing my expertise in CMC submissions, regulatory operations, and global guidelines.
Experience
Apprentice Regulatory Affairs
Aug 2024 — Present · Bengaluru, IN
Working in Content delivery, CMC product variations.
Education
Seventh Day Adventist Higher Secondary School
Secondary school
Rajaram College, kolhapur
Higher Education( Science stream)
Padmashree Dr.D.Y.Patil Institute of Pharmaceutical Science and Research,Pimpri,Pune 411018
Master of Pharmacy, Pharmacy, Pharmaceutical Sciences, and Administration
Bharati Vidyapeeth College of Pharmacy Kolhapur
Bachelor of Pharmacy - BPharm
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