Priyanka Sharmila Chippa

Regulatory Ops | CMC Author | Power BI | Veeva | Global Submissions | Data Analytics | Lifecycle & Compliance | UoH MBA Gold Medalist

Role
Regulatory Portfolio Management Specialist at 百时美施贵宝
Location
Hyderabad, TG, IN
LinkedIn followers
500 followers

About Priyanka Sharmila Chippa

An enthusiastic, career-focused post graduate in Pharmacy, 8th rank NIPER JEE(and also…

Experience

  1. Regulatory Portfolio Management Specialist

    百时美施贵宝

    Jul 2024 — Present

    Working on CMC-PAC Framework development in Power BI, collaborating with IT and independently executing backend changes, enhancing global data reporting and compliance tracking. Served as the CMC Subject Matter Expert (SME), working across teams to optimize global regulatory operations through data-driven tools and visualizations.• Manage Health Authority Query Response Process (e.g, coordinate RRT(Rapid Response Team) meetings, develop response document, research precedence, scheduling placeholder meetings, response document finalization and publishing)• Streamlining submission of CMC Annual Reports• Support Safety and Annual Reporting (e.g, DSUR, PBRER)• Regulatory Intelligence & Analytics: Conducted simple analyses, supported the preparation of analytics and monthly dashboards, showcasing milestones, approvals, and key achievements.• Document Management & Archiving (Veeva Vault & CARA): Led efforts in documenting and archiving CMC submissions and communications within the document management system, ensuring proper tracking and compliance.

Education

  • Kakatiya University (University College of Pharmaceutical Sciences)

    Master's degree

    2013 — 2015

  • University of Hyderabad

    Master of Business Administration - MBA

    2020 — 2022

  • Kakatiya University (University College of Pharmaceutical Sciences)

    Bachelors

    2009 — 2013

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Priyanka Sharmila Chippa — Regulatory Portfolio Management Specialist at 百时美施贵宝 in Hyderabad, TG, IN | Unifers