David McCoubrey, Regulatory Affairs Lead
David McCoubrey, Regulatory Affairs Lead
I usually begin the day by reviewing emails that have come in from the various partner companies around the world that we work with. Then I will work through the next steps in the different projects and tasks that I am involved in. This could be reviewing an analytical testing report for a new medicinal product’s Marketing Authorisation application, or checking a proposed change to an existing product licence before it is implemented. Later in the day I might have a project meeting with staff from another part of Almac, or a teleconference with a client company that we are providing services for.
Almac gave me the opportunity to use my Pharmacy degree and be involved in the development of new medicines. As a large company with a range of scientific roles, it opened up many possible career paths. I also thought Almac was a good option because it is a stable company with strong local roots.
I’ve been involved in the licensing of a new medicinal product, right from the beginning of its development, through the whole application process and resulting in the UK approval of the drug. I also enjoy my role in writing sections of clinical trial applications for drugs that have never been used in humans before.
I think it helps that our department works together as a team to ensure that responsibilities are shared. This means that we support each other in managing projects and that’s especially important during busy periods when deadlines for several tasks coincide. The option of using flexi-time arrangements to leave a little early or come in late, can also make it easier to get that right balance between home and work life.
I studied Pharmacy in Queen’s University Belfast and after graduating in 2006 I did my pre-registration training year in community pharmacy with Alliance Pharmacy. Once I was registered as a Pharmacist, I worked as a Relief Pharmacy Manager with Alliance/Boots Pharmacy in Northern Ireland. I joined the Scientific Affairs department of Almac in 2010 as a Senior Regulatory Affairs Scientist and became a Regulatory Affairs Lead in 2018.
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