Regulatory Affairs Therapy Area Lead Oncology
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Job Summary
Regulatory Affairs Therapy Area Lead - Oncology
Competitive Salary & Benefits
Advert Closing Date: 12th April
Introduction to role:
We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas. This role involves delivering and maintaining competitive licenses for the UK driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities. This includes project leadership and line management. You will also be responsible for the timely delivery of clinical trial approvals and maintaining high regulatory compliance standards for the UK through the provision of local regulatory expertise.
You will also support the development of AZ investigational and in-licensed/ co-development products through valued contributions to MC3 projects study feasibility questionnaires scientific advice meetings and other related activities ensuring full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards
Essential Skills/Experience:
- Life Sciences Degree or appropriate professional qualifications
- Significant experience working within a Regulatory Affairs organisation in a UK-based Global Pharmaceutical company.
- Line management experience/ Experience leading project teams
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Demonstrable negotiation skills and leadership capabilities
- Strong working knowledge of MHRA requirements ideally with experience post Brexit
Desirable Skills/Experience:
- Post-graduate qualification
- Therapy Area Expertise in one of the following diseases or technology areas: Respiratory Cardiovascular Diabetes Renal Oncology injectable biologics inhaled medicines medical devices vaccines
- Experience in creating and delivering regulatory strategies for Orphan drugs applications and/or paediatric indications new MAAs and new indications
- Experience with Clinical trial submissions
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca
At AstraZenecas Biopharmaceuticals Business Unit we are at the forefront of medical leadership across our enterprise and the healthcare ecosystem. We shape the future of Healthcare by nurturing relationships with external experts to do something truly meaningful. We are always broadening our relationships with thought leaders to include policy makers and patient groups. This is a place for strong communicators resilient and fast-paced individuals who bring new ideas to the table then make them a reality.
At AstraZeneca UK we are committed to delivering against three missions:
- Accelerating the position of the UK as a global centre of excellence in life sciences
- Redefining healthcare through fast and equitable access to the most effective medicines high quality care
- Delivering sustainable leadership that prioritises healthy people society and planet
Our head office in Pancras Square offers us the strongest possible platform to transform the lives of patients as the countrys leading biopharmaceutical company. It brings AstraZeneca UK closer to our customers partners and collaborators in the UKs healthcare environment as well as develop greater collaboration with the wider AstraZeneca footprint.
Are you ready to make a meaningful impact on patients lives and your personal growth
Theres never been a better time to join our thriving Biopharmaceuticals team. Apply now!
Date Posted
31-Mar-2026Closing Date
12-Apr-2026Our 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.
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About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
