Welcome Navin!

Navin is the Vice President of Regulatory Affairs and Quality Affairs at Plus Therapeutics. Navin is a dynamic leader who brings over 24 years of strategic and leadership expertise in Regulatory Affairs and Quality Assurance, specializing in Biotechnology, Pharma, Diagnostics, and Medical Devices. He is known for his vision, innovation, and ability to lead high-performing teams in regulated environments. Navin has successfully executed regulatory strategies that have driven the commercialization of cutting-edge therapeutics and technologies, including oncology, urology, AI-based in vitro diagnostics, as well as complex medical devices.  Before joining Plus, Navin served as the head of Regulatory and Quality at Ikena Oncology, Taris (J&J) and Medtronic. His leadership was crucial during two major acquisitions by big Pharma, Johnson & Johnson, and Medtronic, as well as during two IPOs, where he established regulatory and quality functions from scratch.

Navin has been the primary interface with global regulatory bodies for several years, managing successful IND, NDA, 510(k), and PMA submissions and approvals, pre-approval inspections (PAIs), and regulatory audits across the USA, EU, and globally. He has led multiple teams through FDA warning letter remediation and quality remediation projects, achieving compliance and significant certifications, including CLIA and ISO 13485, and managing approval of class 2 and class 3 medical devices. Navin holds multiple master’s degrees, in Drug Discovery & Development and in Systems Engineering from Rutgers University.  Outside of work, he is a proud father, a soccer coach, and enjoys hiking, reading fiction, and exploring new technologies.

In his role at Plus therapeutics, Navin aims to leverage his extensive experience in leading regulatory and quality initiatives to solve complex challenges and drive innovation in medical technologies. His expertise in oncology therapeutics and diagnostics, combined with a proven track record in product development, achieving regulatory approvals and quality compliance will be key in advancing Plus’ nuclear medicine treatments. Navin is dedicated to ensuring the highest standards of safety and efficacy, positioning the organization as a leader in cancer treatment and diagnostics.