Kiran Krishnan

Kiran Krishnan, PhD is the Senior Vice President of Global Regulatory and Medical Affairs at Apotex. Since joining Apotex in 2006, he has been instrumental in shaping the global regulatory and medical affairs strategy for Apotex, managing a worldwide team of regulatory professionals. Dr. Krishnan leads the company’s efforts to develop top-level regulatory strategies, supporting the launch and commercialization of key products across the specialty, biosimilar, and generic portfolios. With more than 20 years of regulatory experience in the generic pharmaceutical industry, Dr. Krishnan has integrated regulatory strategy into the drug development process, and his team has enabled the submission and approval of numerous first products in the generic, specialty, and biosimilar spaces.

Dr. Krishnan is actively involved with the American Association for Accessible Medicines (AAM) and Canadian Generics Pharmaceutical Association (CGPA) scientific and regulatory committees. He was also actively engaged with the US FDA as part of the AAM team to negotiate and develop the commitment letters that formed the basis to reauthorize the Generic Drug User Fee Act (GDUFA) II and III.

Dr. Krishnan holds a Master’s degree in Pharmacy with a specialization in Industrial Pharmacy and a PhD in Pharmacy from the Department of Pharmacy, Annamalai University, India.