Vanshika Sharma
Actively seeking Full-time Opportunities in regulatory and quality domain | Regulatory Affairs Enthusiast | B.Pharm Undergrad | SaMD
- Role
- Regulatory Affairs Specialist at Integra LifeSciences
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Vanshika Sharma
As a Regulatory Affairs Specialist, I manage critical regulatory documentation and ensure…
Experience
Regulatory Affairs Specialist
Jan 2024 — Present · Princeton, NJ, US
Managed regulatory documentation including 15+ DMFs, ANDAs, and 5+ ASMFs submitting updated notifications to authorities like USFDA, EU, and Health Canada- Addressed over 20 NDC registrations, 30+ product submissions with CDER, ensuring 100% accurate labeling and compliance with New Dietary Ingredient Notifications & Claim- Conducted 10+ risk assessments, managed 3 market recalls updating 5 SOPs to ensure FDA compliance handling adverse event reporting- Collaborated with suppliers ensuring testing and regulatory compliance across supply chain supporting Quality Assurance efforts, reducing defects by 10%- Implemented 7 risk management strategies, including CAPA and root cause analysis ensuring 100% timely regulatory submissions using eCTD and RIMS
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy - BPharm, Pharmacy
Northeastern University
Master of Science - MS , Regulatory Affairs- Drugs, Medical devices and Biologics.
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