Regulatory Affairs Manager

ASTRAZENECA UK LIMITED; City of Westminster; On-site; GBP 90,000 - 130,000; Full time

Job summary

AstraZeneca UK Limited is seeking a Regulatory Affairs professional to drive the regulatory strategy for UK initiatives and maintain compliance across defined product responsibilities. You will lead cross-functional projects, contribute to scientific advice, and ensure timely approvals in a fast-paced pharmaceutical environment.

This role requires post-Brexit UK regulatory experience, strong negotiation skills, and the ability to work with MHRA to optimise submissions and lifecycle management

Qualifications

• Life sciences degree or appropriate professional qualifications.
• 4+ years' experience in regulatory affairs 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.

Responsibilities

• Lead regulatory strategy for UK initiatives.
• Ensure regulatory compliance for defined product responsibilities.
• Support cross-functional projects, study feasibility questionnaires, and scientific advice meetings.
• Lifecycle maintenance of UK regulatory licenses, including submissions (CMC, Labelling, etc).
• Develop regulatory strategy aligned with product development and commercialisation strategies.
• Build productive relationships with the MHRA to drive meaningful interactions for patients.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional leadership

Negotiation skills

IT systems

UK regulatory landscape

Education

Life sciences degree

Tools

Veeva systems

Job description

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 & 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.

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.