Harsha Renikunta

Background

About Harsha Renikunta

Certified Regulatory Affairs & cGMP Expert: Possesses in-depth knowledge of global regulatory standards for pharmaceuticals, ensuring compliance, successful product development, and comprehensive expertise in regulatory submissions-including eCTD dossiers. • Expert in Regulatory Navigation: Skilled in guiding products through EMA and FDA standards across key global markets, ensuring compliance throughout development. • Proven Project Management Experience: Successfully managed multidisciplinary teams and complex, high-stakes projects, ensuring on-time delivery and regulatory success. • SOP Development & Implementation: Skilled in designing, developing, and implementing SOPs that ensure regulatory compliance while enhancing clinical trial quality and efficiency. • Patent Success: Experience in successfully filing for cutting-edge RNA-targeted therapies in global markets, including the US, Europe, and Japan. • Clinical Drug Development Expertise: Extensive experience in GMP, GCP, and QMS, ensuring the highest standards of compliance, integrity, and quality in clinical drug trial execution. • Cross-Functional Collaboration: Adept at coordinating with interdisciplinary teams, Clinical Review Boards, and CROs to optimize regulatory and clinical operations, driving project success.