Regulatory Affairs Manager

On-site in London·Full-time·Added today (last checked 26 Oct)

AstraZeneca

41 open roles

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Our summary

Work mode: On-site, London
Contract: Full-time
Experience: 4+ years

Skills

Nice to have

Veeva

Requirements

What we're looking for

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.

Nice to have

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.

The role

Type: Permanent

Location: Pancras Square

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.

What you'll do

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%)

Desirable Skills/Experience

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

26-Oct-2026

Closing Date

09-Nov-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.

Hiring process

2 steps1 interviewa task to do

Application
Recruiter contact · With a recruiter
Assessment
Not every role
Some roles, especially graduate roles, add a game-based assessment, a video or telephone interview, or an assessment day.
Interview
A two-way conversation about your skills and suitability for the role, and a chance for you to find out if AstraZeneca is right for you.
Pre-employment screening
Offer

Candidates who reach interview stage or beyond usually get feedback within 14 days of the role's closing date.
Interview travel expenses are reimbursed for journeys over 100km.
Alcohol and drug testing is carried out for new hires where required by local country legislation.