John Pakulski

Head of Global Regulatory Affairs
35+ Years of Industry Experience

Career History

✔ Leader in global regulatory affairs for biosimilars and served as Vice Chairman of the Biosimilar Council, Chair of the AAM - Biosimilars Working Group, Chair of the Biosimilar Forum Regulatory Committee.
✔ Received 3 leadership awards for shaping biosimilar pathway and policy while at Novartis.
✔ Approvals for over 10 novel biopharmaceuticals, development of over 25 INDs while at Pfizer, Aventis and Sanofi.
✔ Development of over 15 biosimilars including 5 approvals while at Novartis, Mylan & Kashiv, including 1st biosimilar approved in the US.

  • Education

  • • Rutgers College of Pharmacy