Nagendra Verma

WORK HISTORY

EDUCATION

ABOUT NAGENDRA VERMA

I\'m a PhD‐trained biomedical scientist transitioning into a Regulatory Affairs professional, passionate about bringing innovative pharmaceuticals, biologics, and medical devices to market safely, efficiently, and in full compliance with global regulations. I translate complex science into a clear, submission-ready regulatory strategy. With deep hands-on experience across clinical genetics, diagnostic assay development, preclinical oncology, and regenerative medicine, I bridge the bench and the binder to accelerate safe, compliant product development. I’m skilled in IND/NDA/BLA and eCTD documentation, 510(k)/PMA pathways, ISO 13485 and QMSR alignment, risk management, CAPA, and audit readiness. I write precise SOPs, perform gap analyses, and coordinate cross-functional teams to keep projects inspection-ready and on schedule.In addition to developing and documenting experimental protocols, I have conducted data analysis and contributed as an author and review-editor over 170 peer-reviewed scientific publications. These experiences have enhanced my attention to detail and technical writing capabilities, which are highly relevant for preparing regulatory submissions. Furthermore, I have worked collaboratively with interdisciplinary teams to advance scientific discoveries into clinical applications, demonstrating strong communication skills essential for regulatory affairs.My approach to regulatory strategy is pragmatic and science-driven. I focus on implementing high-impact controls, aligning documentation with reviewer expectations, and integrating quality-by-design principles into development plans. I am committed to establishing scalable regulatory processes that accelerate review timelines and enhance post-market compliance.Let\'s connect- I\'m looking for Regulatory Affairs or operations roles. My R&D experience and regulatory training can help with faster market entry.Email; n••••••••@gmail.com