Loganathan Kumarasamy

How did you get into a regulatory career? What do you like about regulatory affairs?

From childhood, I have had a passion for the life sciences, so I chose to study biomedical engineering. After graduating, I started my career as a quality and validation analyst at Zifo Technologies, a company focused on accelerating drug development process. As part of my work at Zifo, I moved to the US in 2015 and gained a better understanding of the need for regulatory professionals in the industry. As a result, I pursued a master’s in regulatory affairs and joined regulatory societies. including RAPS. To me, the importance of regulatory affairs is that it focuses on providing the right solutions and methodologies to safely deliver lifesaving drugs and therapies.

What is a typical day like for you?

Every day is unique and includes opportunities to help my team provide scientific solutions to pharmaceutical labs and manufacturing areas while ensuring appropriate regulatory strategy maximizes quality and minimizes safety risks.

What was an especially memorable moment for you on the job?

Working in the regulatory consulting space provides me the opportunity to engage with many clients who focus on delivering drugs and devices for various unmet needs. Seeing them go through regulatory approvals provides special moments, knowing that we have also contributed in a small way for the success of a drug/device.

How has the RAC and/or your membership in RAPS helped you?

If you look at typical posts on the RAPS’ Regulatory Exchange (RegEx) open forum, you’ll see a wide variety of posts on regulatory, quality, and compliance issues. As a RAPS member, I get to connect with these industry professionals and participate in these community discussions and events.

What advice would you give to someone looking to start a career in regulatory?

Contribute and learn! Actively participating in regulatory community like RAPS is a key to success. It will help you to understand the industry and shape your career path.