Regulatory Affairs Manager reference: R-241558

Regulatory Affairs Manager

Type: Permanent

Location: Pancras Square

Introduction to 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 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 & 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 qualificationsSignificant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical companyPost-Brexit UK Regulatory experienceBusiness Relationship Management and ability to navigate and coordinate cross-functional interactionsOperational regulatory experience in the pharmaceutical industry with time spent in a commercially aware roleDemonstrable negotiation skillsAbility to make optimal use of IT systemsUse of external regulatory environment and scientific knowledge skills to build a productive, positive and trustworthy relationship with local health authorities to drive meaningful interactions to the benefit of patientsLifecycle maintenance of the 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 timelinesDevelopment of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategiesApplication of the knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunitiesApplication of Drug Development KnowledgeAudit and Inspection Knowledge

Desirable Skills/Experience

Therapy Area Expertise in Cardiovascular, Renal & Metabolism (CVRM)Experience with clinical trial applications (CTA)Experience in creating and delivering regulatory strategies for Marketing Authorization Applications and New IndicationsExperience working in Veeva systemsManagement of reaction to change & remaining effective in new work situations & times of uncertainty; Assessment of, planning for & managing the impact on stakeholders arising from changes & applying change management techniques to appropriately engage stakeholdersA robust understanding of the disease and therapeutic area including the regulatory and health technology assessment environment in the major markets, 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

11-Dec-2025

Closing Date

08-Jan-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.