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A week in the (sandy) shoes of a Regulatory Affairs Executive

18 th Sep A week in the (sandy) shoes of a Regulatory Affairs Executive

A week in the (sandy) shoes of a Regulatory Affairs Executive


Clocking off work at the end of the week, ready for some rest and relaxation, is always a good thing. But it’s even better with Cornwall on your doorstep. By 4:30pm on a Friday the beach beckons. Surfers, dog walkers and ramblers alike take to the sandy shores and rolling waves which surround our amazing county. A walk with my family and our dog gives us all some quality time together, followed by a hot chocolate (with marshmallows obviously!) in the café overlooking the beach. The perfect way to start the weekend. Tomorrow I’m meeting a friend for brunch, followed by a walk in the woods and then an afternoon watching my husband play rugby at our local club.

But before we get too relaxed let me tell you a bit about the week that’s just drawing to a close. Getting into work at the start of the week always begins with the usual sorting through the pending tasks, planning and prioritising. An array of varied work types and clients await and you can be certain the week will never run quite as planned! Being mostly desk based, the job is a great mix of independent tasks and collaborative working.

A patient information leaflet beckons as the first task on the agenda. We conduct a detailed review of the texts and propose improvements to the client. Our next readability user test is just around the corner and we want to make sure the leaflet is the best it can be for the members of the public who will be using it on a regular basis. It’s fantastic to know that the changes we have proposed could be the difference between a patient using their medicine correctly and safely or not. Not many jobs have such an important impact.

Following on from this there are several variation dossiers that need preparing for our clients. From large multi-national pharma companies to smaller start-ups, the requirements of each submission can be very different. Some are critical safety updates, others are launching a new manufacturing site and several are changing the packaging of the medicine. Over the course of the week this work progresses, mixed in with internal team meetings about TRAC’s quality management, healthy workplace initiatives and a ‘Bake Off’ tea break.

Towards the end of the week we take part in a multi-national teleconference with a client to help determine the regulatory strategy for a variation affecting markets across the globe. During this meeting, we liaise with colleagues from other countries to establish the most time and cost-effective plan for making the submissions. The opportunity to work with people from a wide range of backgrounds to achieve a common goal is a rewarding and inspiring part of the job. By the end of the week, I’m happy that the planning I’ve done will make the submissions run smoothly once the project goes live. But for now it’s time I get back to that hot chocolate by the beach!

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