Gautam Maitra MTOPRA

Candidate | Director

Current position and relevant professional experience:

I have over 30 years of experience in the pharmaceutical industry in various functions from preclinical to quality to regulatory. Since 2017 I have taken a dual role of fostering innovation from academia and to rendering development advice to the early stage life science companies. 

I served as the Director of Programs for Innovate4Life at the Swiss Federal Institute of Technology Lausanne Campus (EPFL), accelerating research ideas to products, and training students for a life in Pharma and MedTech industry.

Currently I am:
Director, External Affairs for Global BHP BrainTrust
Engaged in an advisory role for two start-ups in Lausanne, Switzerland
A faculty advisory board member of San Diego State University, Center for Regulatory Science, College of Sciences.

Current or previous involvement in TOPRA activities:

I have been a member of TOPRA since December 2023. I have followed with interest the activities of TOPRA at close range and benefited from the explicit an tacit knowledge through website and emails. This has helped me to advice the start-ups with knowledge that one does not find in text books!

I have served as the director of the Parenteral Drug Association and I have served in the Board of RAPS for five years. This, combined with my years of experience and the network that I have built and am still building, should help me in specific areas of the membership needs.

Personal statement:

My experience gives me the credibility to contribute at the level of professional strategy and governance, rather than only technical regulatory advice.

My background is particularly valuable for TOPRA today:
•  Multinational pharmaceutical-company experience
•  Biotechnology/start-up exposure
•  Independent consultancy experience
•  Understanding of the needs of smaller companies that cannot maintain large regulatory departments
•  Understanding of strategic regulatory decision-making inside major organisations.