Priyanka Sharmila Chippa

Global Regulatory Submissions Support & CMC Operations:
• Lead Submission for Annual Reports: Managed and submitted CMC Annual Reports, ensuring regulatory compliance and timely filing.
• Regulatory Submissions & Critical Deliverables: Supported the planning and timely delivery of key regulatory documents, including registration samples and Module 1 documents for ex-US, ex-EU countries.
• Health Authority Engagement: Requested certificates from global Health Authorities (FDA, EMA, Swiss Medic) and managed the notification process for product registrations.
• Document Management & Archiving: Led efforts in documenting and archiving CMC submissions and communications within the document management system, ensuring proper tracking and compliance.
CMC Framework Development & Power BI Integration:
• Led the CMC 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.
Cross-Functional Collaboration & Stakeholder Management:
• Coordinated with cross-functional teams, including Regulatory Operations, Product Leads, and IT to implement streamlined workflows for CMC submissions.
• Acted as a liaison between Regulatory Affairs and other teams, ensuring smooth execution of tasks and timely deliverables.
• Product Divestiture, Deletion, and Termination Support: Managed document uploads for divestitures, gathered information from Country Regulatory Managers on Product Deletions Strategy, and tracked deletion notifications to regulatory authorities.
Compliance, Analytics, & Reporting:
• Regulatory Intelligence & Analytics: Conducted simple analyses, supported the preparation of GRS analytics and monthly dashboards, showcasing milestones, approvals, and key achievements.
• Developed and implemented robust policies and procedures, enhancing overall regulatory compliance and process adherence.
• Enhanced Compliance: Created reports and provided status updates to teams and departments on project progress and activities, ensuring clarity and transparency.
Health Authority Queries & Shortage Notifications:
• Managed Health Authority queries by scheduling RRT meetings, ensuring timely responses to submissions, and setting up response templates for submission readiness.
• Managed shortage notifications, ensuring compliance with reporting timelines and requirements.
Training & Development:
• Training & Knowledge Sharing: Conducted training for staff on select CMC procedures and systems, helping to elevate team competency.
Regulatory Strategy & Global Support:
• Played a key role in executing regulatory strategy by liaising cross-functionally to generate internal milestone reports, ensuring alignment with broader organizational goals.
• Provided global regulatory support by assisting in SharePoint maintenance and supporting GRT member transitions through form setup and process management.

• Adept at eCTD submissions (Original ANDA / DINA / Post approval supplements / Annual reports) and effectively maintained Life Cycle Management of Injectables & OSD (Oncology)
• Well-supported responses to queries in lieu of the Health Authority/Agency guidelines while ensuring accuracy and meeting strict timelines.
• Independently tracked and maintained stipulated regulatory requirements/updates regarding the said projects, pre and post submission phase
• Regulatory evaluation of change controls and change notifications .Effectively handled various other quality events for possible regulatory impact.
• Coordinating between Cross functional teams and review of responses to Health Canada queries (e.g Clarifax, Notice of Non-Compliance, and Notice of Deficiency) to ensure quality, right first-time output to meet timelines
• Review of DMF documents
• Critical assessment of data and documents to identify gaps compared to regulatory requirements for Canada.

• Molecular Oncology - Designed and carried out complex laboratory experiments to determine cytotoxicity of drugs and to assess the effectiveness of Nano-particles
• Compiled the result data in reports & Streamlined research processes for multiple projects.

Publications :

Nature’s – Scientific Report - Impact factor 4.3

Use of Biocompatible Sorafenib-gold Nanoconjugates for Reversal of Drug Resistance in Human Hepatoblastoma Cells.

• Conducted all work in accordance with appropriate regulatory guidance, international pharmacopeias, ICH, GMP, GLPs and applicable standard operating procedures
• Gathered, arranged and corrected research data to create representative graphs and charts highlighting results and gave presentations on the same.