Krishnaben R. Patel

Dynamic Regulatory Affairs professional with 2.5 years of hands-on experience supporting U.S FDA submissions, with a strong focus on New Drug Application (NDAs), including combination products. Adept at navigating complex regulatory frameworks, including FDA regulations, ICH guidelines, and ISO 13485/14971 standards. Proficient in preparing, compiling, and reviewing high-quality regulatory documentation to support product development, market approval, and post-marketing compliance. Experienced in managing post-approval activities such as labeling updates, CMC amendments, and annual reports in full alignment with FDA requirements. Possess a solid foundation in analytical sciences, with prior lab-based experience in bioequivalence/bioavailability (BE/BA) studies and method validation under GMP/GLP-compliant conditions. Recognized for effectively translating complex scientific data into regulatory narratives and collaborating cross-functionally with QA, R&D, and clinical teams to drive regulatory alignment and project success.

Regulatory professional prepared for role demanding meticulous attention to compliance and regulatory standards. Expertise in managing regulatory submissions and maintaining thorough documentation. Known for effective teamwork and adaptability in dynamic environments. Proven ability to interpret regulatory guidelines and communicate effectively with stakeholders.

• Developed a master reference list of NDA approvals, CRLs, and IRs by centralizing key agency communications and responses to enhance submission quality, reduce response time and support regulatory strategy development.
• Created and maintain a comprehensive master list of NDA backbone submission documents from project inception documents accessibility, ensuring regulatory compliance and enhanced submission readiness for a small regulatory affairs team.
• Transitioned FDA submission activities for drug-device combination product from third party consultant to internal ownership, leading CDER Direct Submissions (establishment registrations, drug listing, labeler code) and GUDID UDI entries, improving accuracy, cost reduction and reducing regulatory submission turnaround by 10%.
• Established in-house eCTD publishing capabilities using Extedo, streamlining regulatory submission workflows and eliminating reliance on external publishers, enabling faster response to agencies concerns and enhanced document control across functional teams.