Regulatory Affairs Associate at GSK
What are your main work activities in your current role?
I am currently in my first rotation in the department that coordinates the submission of regulatory documents for the EU and the rest of the world except USA and Japan for new products. My specific role involves a lot of project management and coordination between different business units to ensure that the relevant documents are submitted on time and without errors. I also need to make sure that all our submissions are in line with the requirements set out by the agencies.
I will be moving onto labelling (patient information leaflet) soon followed by the Chemistry Manufacturing and Controls groups.
What route have you taken to reach your current role?
After finishing my PhD I was looking at a variety of different roles. Regulatory affairs stood out as one where I could bridge my interest of the pharmaceutical industry with my scientific background whilst having a clear career progression and a good work-life balance.
I applied to the GSK Future Leaders Programme in Regulatory Affairs (one of the few graduate programs in regulatory affairs) and after the numerous selection rounds I was offered the position! The professional development opportunity and breadth the scheme delivers is unmatched, so accepting the offer was a no brainer.
What do you find most enjoyable and most challenging about your job?
I am really enjoying the fast pace and the interaction with many different business units as well as the various regulatory agencies. I enjoy the challenge of having to learn about new things and immediately applying them. I also enjoy that I have specific product responsibilities, so can really see the impact I am having. I also like the life-work balance, most of the submissions and other activities are planned well in advanced, so it's easy to manage your time and go home at very reasonable hours.
What I have found most challenging is the fact that I am no longer an “expert” in what I am doing. At the end of my PhD I had a deep understanding of the state of my field, of who is who and of the subject specific knowledge. Although I went into my role with some basic understanding of regulatory affairs, I am starting essentially from the bottom, which would not have been the case if I'd have pursued a post-doc for example. I am also finding it difficult to grasp the enormity of the machine that is involved in developing, regulating and marketing a new medicine. Unlike during a PhD where one tends to be the sole driver of a project, especially in a large company like GSK, you are one of the many pieces and it can often be frustrating and out of your control when things stall.
What advice would you give to a current Postgraduate Researcher interested in working in regulatory affairs?
Be proactive. There are few opportunities to get into a regulatory affairs role straight out of university (either UG or PG), so it’s really a question of looking and persevering. I would also suggest having some idea of how a medicine is approved and what the key elements of a submission document are. Groups such as TOPRA (The Organisation for Professionals in Regulatory Affairs), RAPS (Regulatory Affairs Professionals Society) and ABPI (Association of British Pharmaceutical Industries) have some great resources on their websites that are worth reading up on.
Apart from the couple of graduate schemes, the MHRA (UK medicines agency) has entry level roles that you can apply for without direct experience and some smaller consulting companies will take graduates on. I would also say that having a PhD is a definite advantage, both for getting your foot in the door and for career progression. During my assessment centre, half of those that attended had a PhD! I also find that the experiences I gained throughout my PhD have made me more confident to tackle new problems and interacting with senior people. When applying for roles see yourself as more than an expert on your thesis subject, highlight your professional maturity and integrity!
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