AstraZeneca
Regulatory Affairs Manager
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Regulatory Affairs Manager
Regulatory Affairs Manager
Type: Permanent Location: Pancras Square, London
About 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. This includes project leadership and timely procurement of clinical trial approvals, while upholding the highest compliance standards through local expertise.
Support the development of AstraZeneca’s investigational and in-licensed/co-development products by contributing to:
- Cross-functional projects
- Study feasibility questionnaires
- Scientific advice meetings
- Related activities
Ensure full compliance with GxP (Good Practice) requirements, incorporating local Quality Management System (QMS) SOPs and AstraZeneca policies and global standards.
Accountabilities
- Generate Competitive Licences (0–40%)
- Regulatory Compliance & Governance (0–10%)
- Commercial Support (0–15%)
- Formulate and Influence Regulatory Strategy (0–15%)
- Leadership & Productivity Improvement (0–10%)
- Clinical Support (0–10%)
Essential Skills & Experience
- A life sciences degree or equivalent professional qualifications
- 4+ years’ experience in a Regulatory Affairs role, preferably within UK-based or global pharmaceutical companies, including:
- Post-Brexit UK regulatory experience
- Strong business relationship management and cross-functional coordination
- Commercial awareness within regulatory operations
- Negotiation, stakeholder engagement, and IT system proficiency
- Scientific knowledge and expertise in navigating regulatory landscapes while building trust with health authorities
- Ability to maintain UK regulatory licences, including submissions (e.g., CMC, labelling)
- Optimisation of submission processes aligned with global timelines and quality standards
- Regulatory strategy development supporting disease-area strategies, secure competitive advantage, and align with commercialisation goals
- Compliance focus embedding regulatory excellence, risk mitigation, and business opportunities
- Understanding of Drug Development Knowledge Audits and inspection readiness
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Desirable Skills & Experience
- Oncology therapy area expertise
- Clinical trial application (CTA) and trial maintenance experience
- Marketing Authorisation Applications (MAA), new indication strategies
- Veeva system experience
- Change management capabilities, ensuring resilience amid uncertainty
- Stakeholder impact assessment under changing conditions
- Deep therapeutic knowledge covering regulatory, HTA (Health Technology Assessment), competitor, and development challenges
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About AstraZeneca
AstraZeneca is driven by the mission to change practice of medicine, generating evidence-based solutions that empower physicians to improve patient journeys including CRC (Cancer Research &* Care).
As an enzymologically diverse team, we foster an environment:
- Supporting career growth
- Impact-driven work with ** tiefen contributions to patients**
- Deep transparency, collaboration, and ambition
Applying now could mean shaping cancer care, fostering inclusion, and helping AstraZeneca remain a leading force in pharma and scientific innovation.
Inclusion Statement AstraZeneca is committed to an equitable and inclusive workplace. Every qualified candidate, regardless of background, is encouraged to apply. Reasonable adjustments will be made available through the recruitment process.
Ready to apply? Date Posted: 23-Jun-2026 Closing Date: 04-Jul-2026
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