Harsha P L
I am Harsha P L, I am a Registered Pharmacist. Regulatory Affairs Professional | Experience in RIM Systems, US/EU Submissions & ICSR Processing | M Pharm | TCS & IQVIA
- Role
- Senior Process Associate at Tata Consultancy Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Harsha P L
Pharmaceutical postgraduate with 5+ years of hands-on experience in Regulatory Affairs…
Experience
Senior Process Associate
Apr 2022 — Present
Working for HRM on RIM platform LIQUENT InSight. Adept in working on CALYX RELIANT 2.0 and ORION for Events creation (Supplement CMC/ Administrative considering the impact on Module 1 and 3) for NDA, IND, MAA, BLA applications.• Handling HRM related queries by liaising with cross-functional teams and CRA to ensure compliance with regulatory standards.• Product Detail Set creation and updates for created events.• Maintaining 100% quality for US, EU (MRP, DCP, and National Procedures), and MHRA markets, compliance with working standards.• Assigning delegated tasks to team members, ensuring efficient workflow and timely project completion.• Performing the Mailbox monitoring and maintenance, Data management.• Serving as QCer to ensure team deliverables met established standards and maintained high levels of accuracy and consistency.To carry out other responsibilities as and when assigned by the management.
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