Please introduce yourself and what you do
My name is Gilbert Amoateng. I am a Regulatory Affairs iCMC EMEA intern at MSD and I currently study Pharmaceutical and Cosmetic Science at De Montfort University.
My main responsibility is to guarantee that all MSD drugs comply with the regulatory requirements of the country where they will be supplied. We strive to ensure that the Chemistry and the Manufacturing of the drug are consistent with what was produced and shown to be effective in the clinical trials. Additionally, we aim to demonstrate to the health authority that sufficient Controls are in place to maintain the drug's safety for patient use..
What do you enjoy most about your role?
What I enjoy the most about my role is that it’s consistently evolving. Those who work in the regulatory affairs field can confirm that regulations undergo frequent and impactful changes, affecting our regulatory strategies and initiatives. This is particularly evident when working in a global capacity, as changes in regulatory requirements within one region can significantly influence and shape the regulatory expectations in other regions as well. This means that as a regulatory affairs professional it is essential to have a thorough understanding of the regulatory landscape and continuously educate oneself to adapt and evolve accordingly. As a result, the work in this field often remains interesting and engaging.
What was your route into industry from education?
My route into the industry from education is yet to be concluded as I have one more year of university left (wish me luck) but I can say with relief so far so good. I am currently part of the MSD industrial placement programme, specifically in the regulatory affairs iCMC team. One valuable experience that greatly contributed to securing this role was my internship at a manufacturing site, where I worked in the manufacturing department. This experience played a key role in my professional development and prepared me for my current position.
Moreover, my educational background further supported my journey as I gained a solid understanding of key manufacturing processes. This understanding greatly aided me in comprehending the composition of scientific documents, which play a vital role in regulatory filings. As a result, my educational background served as an additional advantage in my role, allowing me to navigate the regulatory landscape more effectively.
Did you always aspire to work in pharma?
I didn’t have my heart set on working in the industry, but I always wanted to work in the health and life sciences field in some capacity, but I wasn’t sure about exactly what I wanted to do. In university, I heard about medical regulations and from there I did some digging and found out more. I learnt about the EMA, and the eCTD and decided regulation was something I was willing to learn and do and that’s when I began looking for an opportunity to experience within this field.
Has your experience in pharma been what you expected or has it been different?
My experience in Pharma has been different to what I expected. There is a negative preconception of the pharmaceutical industry; that there are empty-suit giant overlords pressing big red buttons to spread disease around the world and then magically supply a cure. This of course is hyperbole, but the more you hear this conspiracy theory you end up taking in some part of it. What I picked up was the empty suit aspect of this preconception. That people are serious all the time and all they care about is work. When really, it is normal everyday knowledgeable people just looking to make an impact on the world. The work is also interesting, you really get a chance to merge science with project management, strategy, and legislation. I didn’t have an expectation of the role but looking back on my time here nothing I had done prior could have prepared me for the role.
What are your future aspirations with your career in pharma?
My future career aspirations in pharma are yet to be determined but I am heavily considering a career in regulatory affairs especially in a CMC/strategy-based role. I am also interested in being a QP and other roles but honestly, who knows what I will start out as and later pivot into. So, I am keeping all my options open.
What tips would you give a new starter interested in getting into pharma
Tips I would give to a new starter interested in getting into pharma is to demonstrate a wide range of technical and soft skills, in particular soft skills, you have to work with a wide range of people to achieve a common goal, so soft skills are imperative to any role in the industry. The ability to speak to people and work with them will take you very far. Also, you will experience imposter syndrome as you will be working with people with years of experience where you have practically none. It is okay to feel that way, but the most important thing to remember is to ask questions and identify the resources you will need to grow your knowledge. If possible, I also recommend you get a mentor or two that can teach you the ropes and point you in the right direction.