Regulatory Affairs Manager

• 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%)

• 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.

• 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.