Regulatory Affairs Graduate 2022

Who we are

For more than a century, our organisation has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our organisation continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification for the fourth year running.

Job description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

24 Month Graduate scheme encompassing three 8-month rotations in International Regulatory CMC, Regulatory Operations, and Country Regulatory Affairs UK, based at our Moorgate, London office.

8 months in international regulatory international CMC

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 deliver right first-time regulatory submissions. As part of the EMEA team you will be one of the regional experts for CMC in Europe, Middle East and Africa.

Duties and responsibilities

• Generate regulatory CMC strategies and Learn and apply regulatory policy
• Assess changes to dossiers in the EMEA region and review submission packages
• Liaise with colleagues across the region and globally
• Work alongside our team in health authority interactions and engagements
• Work alongside our team to deliver on operational excellence projects and best practises for regulatory science

8 months in regulatory operations international

Regulatory Affairs Operations International Europe, Middle-East and Africa (RAOI-EMEA) supports the regulatory submission planning and execution process for the whole of the EMEA portfolio.

As a member of the cross-functional team and for the assigned products, they will manage all operational aspects for submission planning and execution of Original Marketing application and post-approval regulatory changes.

Duties and responsibilities

• Learn how to plan and manage regulatory operation projects from authorization through to delivery to country regulatory affairs teams and/or Health Authorities.
• Help in developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
• Steer or participate in cross-functional forums and meetings.
• Support the submission assembly and delivery process with the Global and/or Regional Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the established timelines.
• Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
• Maintain knowledge on the European and non-European procedures

8 months in country regulatory affairs UK

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 including.

Duties and responsibilities

• Developing regulatory strategy and contributing to regulatory filing activities and documentation for new marketing authorisation (MA) applications and product launches.
• Life-cycle maintenance of all aspects of the MAs registered particulars.
• Work alongside our team in MHRA interactions and engagements.
• Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, and ensure regulatory compliance with legislation and company approval systems.
• Developing and maintaining a knowledge of European and UK regulatory legislation and guidelines.
• Work alongside our team Contributing to departmental meetings, ad-hoc projects and issues.

Requirements

• You will be looking to complete BSc in a scientific discipline such as chemistry, biological sciences, engineering, or a related field. Fields of study include (but are not limited to) Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry (or equivalent qualification)
• Demonstrates numerical and analytical skills
• Operates with a high level of integrity, transparency and accountability
• Comprehends and aligns with our organization’s core values
• Aligns and fosters a culture of diversity and inclusivity
• Demonstrates initiative, proactivity and academic curiosity
• Encourages and boosts their colleagues through teamwork
• Demonstrates clear and effective communication
• Demonstrates a desire to learn and improve their performance through feedback

Ability to work both independently and collaboratively in a team structure

Throughout the 24 month scheme you will receive guidance and mentoring to not only help you through your current role, but also to prepare you for applications to permanent roles within the organisation, with the aim that you will continue your career journey with our organisation.