Rutuja M. Chaudhari

Regulatory Affairs Executive | October 2023 – Present

• FDA Submissions & Liaison: Manage the end-to-end process for FDA applications, including the strategic drafting of application documents and persistent follow-up to ensure timely approvals and status updates.
• Regulatory Query Resolution: Address deficiency letters as key technical writer; author scientific rationales and detailed justifications to resolve complex queries from regulatory agencies.
• Dossier Compilation & Management: Lead the end-to-end preparation and compilation of customized dossiers (CTD/ACTD) for global health authorities; proactively monitor dossier lifecycles to ensure submissions remain compliant with evolving international standards.
• Technical Quality Assurance: Review analytical lab reports—including stability data and method validations—to ensure alignment with regulatory specifications and dossier documentation.
• Strategic Collaboration: Liaise with third-party laboratories and internal R&D/QA departments to validate that all analytical procedures and documentation meet stringent compliance requirements.
• Financial & Operational Oversight: Verify lab testing invoices against services rendered, identifying and resolving financial discrepancies to maintain budgetary accuracy.