Type: Permanent
Location: Pancras Square, London

Introduction to the role
Deliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities, including project leadership. Achieve timely delivery of clinical trial approvals and maintain high regulatory compliance standards for the UK through the provision of local regulatory expertise. Support the development of AstraZeneca investigational and in-licensed/co-development products through valued contributions to cross-functional projects, study feasibility questionnaires, scientific advice meetings, and other related activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.

Accountabilities

• Generate Competitive Licences (0-40%)
• Regulatory Compliance and Governance (0-10%)
• Commercial Support (0-15%)
• Formulate and Influence Regulatory Strategy (0-15%)
• Lead the Organisation and Improve Productivity (0-10%)
• Clinical Support (0-10%)

Essential Skills/Experience

• Life sciences degree or appropriate professional qualifications.
• 4+ years experience working within a regulatory affairs organisation in a UK-based or global pharmaceutical company.
• Post-Brexit UK regulatory experience.
• Business relationship management skills and the ability to navigate and coordinate cross-functional interactions.
• Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role.
• Demonstrable negotiation skills.
• Ability to make optimal use of IT systems.
• Knowledge of the external regulatory environment and regulatory science expertise support building a productive, positive and trustworthy relationship with the UK MHRA to drive meaningful interactions to the benefit of patients.
• Lifecycle maintenance of UK Regulatory licenses, including different types of submissions, including but not limited to CMC, Labelling, etc.
• Optimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines.
• Development of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies.
• Application of knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities.
• Application of drug development knowledge.
• Audit and inspection knowledge.

Desirable Skills/Experience

• Experience with clinical trial applications and trial maintenance activities, including the use of in-vitro diagnostics (IVDs) in the clinical trial setting.
• Experience using AI solutions to simplify and improve departmental processes/ways of working.
• Experience in creating and delivering regulatory strategies for marketing authorisation applications and new indications.
• Experience working in Veeva systems.
• Management of reactions to change while remaining effective in new work situations and times of uncertainty; assessment, planning and management of the impact of changes on stakeholders; and application of change management techniques to engage stakeholders appropriately.
• A robust understanding of a relevant disease and therapeutic area, including the regulatory and health technology assessment environment in the major markets, the competitor landscape, and predictable barriers/obstacles in development.

At AstraZeneca, we change the practice of medicine by generating compelling medical evidence that helps physicians better treat patients at every point in their journey. Our cross-functional teams work seamlessly together, leveraging diverse skills to advance our pipeline and redefine cancer treatment. We foster a culture of openness, transparency, ambition, and drive. Here, you will find a supportive environment where you can grow your career while making a significant impact on patients' lives.

Ready to make a difference? Apply now!

Date Posted: 26-Oct-2026
Closing Date: 09-Nov-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Our Philosophy
AstraZeneca is a global, science-led, patient-focused pharmaceutical company committed to excellence in the research, development and commercialisation of prescription medicines. With approximately 90,000 people in 85 countries, our aim is simple: to unlock the power of what science can do, for people, society and the planet. From Clinical Development, Regulatory and Medical Affairs to Finance, IT, Digital, Manufacturing and Supply, the opportunities to make an impact are limitless. Our workforce reflects the diversity of the patients we serve – it is embedded in everything we do. We're at our best and most creative when we seek out different perspectives, experiences and strengths. At AstraZeneca, you'll have the chance to grow your abilities, skills and knowledge constantly in a place that never stands still. Discover why we're a great place to work and see what science — and you — can do.

Apply through our website