Regulatory Affairs (Pharmaceuticals R&D)
What’s this area all about?
The Regulatory Affairs team ensures that all new drugs meet the most rigorous standards set by the regulatory bodies across the world. We collect, collate and evaluate scientific data which confirms the quality, safety and efficacy of our medicines – all while keeping track of changing global health authority requirements. These standards must be met as part of the registration processes for clinical trials and marketing approvals across the world. Join us, and you’ll get the chance to work with other functions across the business, offering guidance and scientific expertise wherever you can.
What is this career path like?
You’ll have the chance to improve your technical skills while gaining valuable leadership training through a combination of mentoring, classroom sessions and on-the-job training. This experience will equip you to become a leader of the future and will provide you with a solid foundation for a variety of careers within the pharmaceutical industry.
Regulatory Affairs includes a wide range of responsibilities and fields of expertise, and you’ll experience many of them on this graduate career path. In a series of rotations over a two-year period, you’ll spend time in at least four of the following teams:
Defining and implementing the global regulatory strategy, interacting with project teams and regulatory agencies, and focusing on the data that supports the clinical efficacy and safety of our products.
Chemistry, Manufacturing and Controls (CMC)
Supporting data for drug substance, formulation development and manufacture which underpins the quality of our medicines.
Providing the writing partnership between non-clinical research, development of scientific disciplines and regulatory affairs.
Ensuring information for prescribers (doctors and pharmacists) and patients is accurately and clearly expressed and maintained.
Quality & Risk Management and Professional Development
Providing the regulatory governance and training.
Publishing regulatory dossiers, supporting management of submissions and records.
Regionally focused teams supporting Europe, Emerging Markets / Asia Pacific and North America, including Policy and Regulatory Intelligence.
You’ll get to work on products across a number of therapy areas, which may include respiratory, cardiovascular, immuno-inflammation, infectious diseases, neurosciences and dermatology. You’ll also be working with scientists and physicians with all kinds of expertise, plus our regulatory colleagues throughout the world.
How will it help my career prospects?
We aim to give talented individuals the chance to learn about drug development and registration across the many areas described above. You’ll play your part in active, exciting teams who are enabling medicines to reach patients in countries all over the world. At the end of the training programme, you’ll have gained broad experience as a Regulatory Affairs professional who can lead, influence and enable the drug development and registration process. The variety of challenging placements you’ll experience during the programme will help you develop your business skills and your understanding of the pharmaceutical industry.
What will I learn?
You’ll follow a structured development programme that incorporates business leadership training and technical training. We’ll help you build knowledge of the drug development process, as well as regulatory agency guidelines and expectations. You’ll also learn about the principles of regulatory agency review processes in Europe, Emerging Markets, Asia Pacific and North America.
Where will I work?
Our Regulatory Affairs (R&D) career path is available in the United Kingdom.
What will be expected of me?
We’ll expect you to manage projects and prioritise a series of tasks effectively. This means you’ll need to build working relationships with people at all levels of our organisation. Not least, we want you to keep developing new skills and knowledge wherever you find the opportunity.
What do I need to succeed?
We’re looking for graduates or post-graduates with a Life Sciences degree. You’ll also need ambition, a genuine interest in the pharmaceutical industry and a self-motivated, proactive approach. We’re looking for clear, effective communicators who can quickly build a rapport with a wide range of people. It’s also important that you can adapt to change and keep focused when the pressure is on. While you’ll have drive, you’ll also be a real team player who actively collaborates with others. In addition, you’ll need an analytical mind, a talent for multi-tasking and the ability to influence others.