Graduate - Regulatory Affairs

12 months in International Regulatory Affairs CMC

In Regulatory CMC (Chemistry, Manufacturing and Controls) our experts maintain the scientific and technical aspects of products that ensure patients receive medicines that are manufactured and tested to a high quality and within compliance of the requirements of the world's Health Authorities. International Regulatory Affairs CMC is a key component of our company's strategy to build regional Chemistry Manufacturing and Controls regulatory knowledge and effective local relationships with country offices to deliver appropriate regulatory strategies and on-time regulatory submissions. As part of the EMEA team you will be one of the regional experts for CMC in EU, Eastern Europe, Middle East and Africa.

• Learn, assess, and apply regulatory policies, internal processes, and systems.
• Support the development of regulatory strategies and the review of submission packages for the EMEA region.
• Contribute to new marketing authorisation submissions and product lifecycle management activities.
• Collaborate with colleagues across the region and globally to deliver regulatory objectives.
• Participate in health authority interactions and support regulatory engagement activities.
• Contribute to operational excellence and regulatory science initiatives while developing digital skills through the use of innovative tools and technologies.

The Country Regulatory Affair team in the UK manages a broad portfolio of prescription medicines for the UK, largely across the vaccine, oncology and infectious disease therapeutic areas and this role is accountable for undertaking a variety of regulatory activities across a range of products for the UK market.

• Support the development of regulatory strategies and regulatory submissions for new marketing authorisation applications and product launches.
• Contribute to the lifecycle management of marketing authorisations, ensuring ongoing regulatory compliance.
• Participate in MHRA interactions and support regulatory engagement activities.
• Support the development and maintenance of patient information leaflets, packaging components, and artwork, in line with regulatory requirements and company procedures.
• Develop and apply knowledge of UK and European regulatory legislation, guidelines, and processes.
• Contribute to departmental projects, meetings, and cross-functional initiatives across the Regulatory Affairs team.

Requirements:

• Currently studying towards, or have obtained within the last two years, a BSc degree (or equivalent qualification) in a scientific discipline, such as Chemistry, Biological Sciences, Engineering, Pharmacy, Microbiology, Virology, Molecular Biology, Biochemistry, or a related field.
• Strong communication and teamwork skills, with the ability to work effectively both independently and collaboratively.
• Demonstrates integrity, accountability, and a commitment to diversity, inclusion, and organisational values.
• Shows initiative, proactivity, and academic and digital curiosity, with a desire to learn and develop through feedback.
• Strong organisational skills and attention to detail.

• We do not provide sponsorship for UK work visas during or after the graduate program.
• To be eligible for the 2-year program, you must have the right to work in the UK for its entire duration (Until August 2029).