N. Dinesh K.
About N. Dinesh K.
N. Dinesh K. is the Head of Quality in Pharmaceutical Development at pSivida, where he has worked since 2010. He has extensive experience in regulatory compliance, quality management, and pharmaceutical development, with a strong academic background in Pharmaceutical Sciences.
Current Role at pSivida
N. Dinesh K. serves as the Head of Quality, Pharmaceutical Development at pSivida, a position he has held since 2010. In this role, he oversees quality assurance processes and ensures compliance with regulatory standards. His responsibilities include managing the quality release of clinical samples, which involves Qualified Person (QP) duties. He has led both internal and external audits to maintain adherence to regulatory requirements.
Previous Experience in Pharmaceutical Development
Before joining pSivida, N. Dinesh K. held various positions in pharmaceutical development. He worked at Advanced Gel Technology Limited as a Senior Research Scientist from 2008 to 2010. Prior to that, he was a Formulation Development Scientist at Sanofi in France from 2006 to 2008. His earlier roles include being a Research Scientist at Orchid Pharma in Chennai from 2001 to 2002 and a Part-time Scientist at Nektar Therapeutics in Bradford from 2004 to 2005.
Educational Background
N. Dinesh K. has a robust educational background in pharmaceutical sciences. He earned a Doctor of Philosophy (PhD) from the University of Bradford, where he studied from 2002 to 2005. He also holds a Bachelor of Pharmacy (M.Pharm.) from the University of Madras, completed between 1995 and 1999. Additionally, he obtained a Diploma in Controlled Release Technology from the Massachusetts Institute of Technology, studying from 2014 to 2015.
Regulatory Expertise and Compliance
N. Dinesh K. possesses extensive experience in generating regulatory documents for drug and device approvals, including IND, BLA, CTD, PMA Class III, and CE. He has a keen insight into regulatory expectations in emerging markets such as CDSA, MFDS, and CFDA. His expertise extends to leading complex business transformations and projects that align with organizational objectives and timelines.
Leadership in Pharmaceutical Projects
Throughout his career, N. Dinesh K. has played a key role in technology transfer and process scale-up for manufacturing, both in-house and with Contract Manufacturing Organizations (CMOs). He has been involved in formulating business strategies, budgetary planning, and financial management to support organizational goals. His leadership has been instrumental in ensuring successful project outcomes in the pharmaceutical sector.