Sunny Panwar

Worked through the entire regulatory lifecycle of a product in Molecular Diagnostics, Companion Diagnostics (CDx), Tissue Diagnostics, Point of Care (PoC) / Near Patient Tests (NPT), and SARS CoV-2 products (COVID-19 test kits) for regulatory submissions of Import License Applications, Test License Applications

- Developed and managed regulatory action item tables to ensure compliance with country-specific requirements. - Incorporated follow-up items and implemented ongoing monitoring and issue escalation processes to ensure successful project deliverables. - Ensured the quality review of documents before submission to health authorities to ensure submission readiness. - Coordinated with cross-functional teams to collate labels and COA's of API, excipients and finished products to support product portfolio.

- Worked through the entire regulatory lifecycle of a product. - Worked on internal document requisition portal “Regulatory Information Management System (RIMS)” to requisition, prepare, and track product documents. - Handled multiple global projects involving digital health, RIMS, safety reporting, and post-approval changes. - Participated in the policymaking and enforcement of MDR-2017 and other related Rules as per Roche Policy - Working knowledge of MDR 2017, EU MDR, EU IVDR, US FDA and ISO 13485.

- Monitored and analyzed relevant regulatory activities for compliance - Prepared and submitted applications for generic drug manufacturing - Regularly followed up with Licensing Authorities and coordinated with in-house departments for "Tech Transfer" - Led regulatory submissions for completeness, accuracy, and compliance with agency regulations and mitigated product development risks.

- Proactively planned for all regulatory submissions based on business requirements and new requisitions from Business Area (BA) - Well-versed with regulatory requirements of Non-IVDDs and IVDDs and ISO 13485. - Gained understanding of technical data, administrative/legal documents, Device Master File, Plant Master File received from different countries for submission to Indian Regulatory Agency. - Drafted regulatory/administrative documents for submissions of application.