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My Experience in Regulatory Affairs

24 Apr 2018

Time really flies. It’s been more than 10 years since I graduated from the MPharm programme offered by the International Medical University and University of Strathclyde. I took the road less traveled and started my career in the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health focusing on regulatory affairs.

On my first year, I rotated in various departments within the NPRA and was exposed to a wide range of regulatory activities including registration, Post Market Surveillance activities, Good Manufacturing Practice audits and even lab testing. After my housemanship, I focused on Post Market Surveillance for Health Supplements and then moved on to the Cosmetic Department in NPRA.

My experience in the Cosmetic Department was a really interesting one, it was there that I found my passion in cosmetics. I also had the privilege to have first-hand working experience in the end to end process of a cosmetic product, from the notification of a cosmetic product to the Post Market Activities such as complaint handling, product claim evaluation and even drafting and issuance of press releases for banned products. Throughout my 8 years tenure in the NPRA, I had the opportunity to attend a cosmetic workshop in Korea which focused on the research and development of a cosmetic product. It was truly an eye opener to see the interesting process that goes behind the creation of a cosmetic product.

After building a solid foundation in regulatory affairs, I decided to challenge myself further and moved on a regulatory affairs lead position for the consumer division in a multinational drug company. My responsibilities include ensuring that our products comply with the ever-changing regulatory landscape. We give strategic regulatory and technical advice to the company, right from the beginning of the development of a product, contributing to the commercial and scientific success of a product and the company as a whole.

The other memorable experience I had was speaking live on national radio about the safe use of cosmetic products. It was really nerve wrecking but also exciting at the same time. I also had a chance to emcee various international and local events organised by the NPRA. My contributions to the organisation led to the award of excellent service by the Ministry of Health Malaysia. Looking back at my years of study, IMU has provided me with the foundation that made me discover my potential in the pharmaceutical industry. Throughout my years studying here, I developed confidence, resilience and learned the meaning of teamwork and working smart. IMU focused on academic and also soft skills that enabled me to navigate through the challenging working environment, work well with others and ultimately achieve my goals.

My advice to juniors is to not be afraid of hardships and challenges as these are great platforms and opportunity to learn and grow. Overcoming these obstacles and challenges, can make one more determined, resilient and builds character.

Written by IMU Alumna, Jasmine Lee

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