Regulatory Affairs Assistant Full Time NEW

Location: Pancras Square, UK

Introduction to the Role

We’re looking for a Regulatory Affairs Assistant to join our Medical and Scientific Affairs Directorate. In this role, you’ll provide administrative, operational and compliance support to the Head of Regulatory and the wider Regulatory Affairs team, helping to maintain accurate data and documentation, support team processes and ensure activities are delivered efficiently in a regulated environment.

This is a great opportunity for someone who is highly organised, proactive and detail focused; with experience in regulatory, compliance or quality environments, and who is ready to grow their skills in a supportive, fast‑paced and highly regulated setting.

The ideal person will enjoy enabling others, taking ownership of key support activities, identifying opportunities to improve how the role operates, and developing enough understanding of regulatory language and context to work confidently to support a team of Regulatory profressionals.

What You’ll Do

You’ll provide administrative, operational and compliance support to the Regulatory Affairs team, helping to ensure our products, documentation and internal processes remain accurate, well managed and compliant.

You’ll work across a broad range of activities, including regulatory support, data and document management, project coordination, reporting and team administration, always ensuring alignment with Good Regulatory Practice (GRP) requirements, the Quality Management System (QMS) and relevant policies and standards.

Regulatory Affairs, Compliance & Project Support

• Assist with compiling regulatory files and support product registration and licence maintenance activities.
• Maintaining databases, supporting clinical documentation archiving and quality checks and uploading documents to internal and external platforms (e.g. Veeva Vault, eMC).
• Maintain regulatory and technical archives, ensuring documentation is audit ready and accurately tracked.
• Assist Regulatory team members with global and regional submission plans for allocated products and projects.
• Coordinate simple submissions such as parallel import applications or Freedom of Inforation (FOI) responses.
• Update templates, coordinate team training activities and maintain status‑tracking materials.
• Prepare and share reports on key metrics, overdue activities, issues, actions and risks (e.g. Quality Events (QE’s).

Administrative Support to the Head of Department & Regulatory Team

• Support finance‑related activities including budget tracking, invoice monitoring, annual fee payments and cross‑charging activities.
• Raise and track purchase orders in Coupa, ensuring timely processing of supplier payments.
• Liaise with (and act as a point of contact) internal and external stakeholders (e.g. Health Authorities), including vendors and finance contacts, to help resolve queries and maintain accurate records.
• Coordinate training activities, update training matrices and maintain documentation.
• Maintain departmental distribution lists, organisation charts, planning calendars and product responsibility lists.
• Develop and improve administrative systems and ways of working.
• Organise meetings, onboarding and offboarding activities, team events and other departmental logistics.
• Produce accurate documentation including minutes, agendas, reports and presentations.
• Provide inbox cover for the regulatory mailbox during absences.

Essential Skills & Experience

• Experience working in regulatory, compliance or quality departments.
• Strong understanding of local SOPs, codes and regulatory systems.
• Experience supporting multiple managers and large teams, with strong prioritisation skills.
• Proven ability to deliver small projects and handle challenging deadlines.
• Experience organising meetings and managing diaries.
• Strong administration and secretarial skills.
• Excellent communication and interpersonal skills.
• High attention to detail and accuracy.
• Strong Microsoft Office skills (Outlook, Word, PowerPoint, Excel).
• Ability to work effectively under pressure.

Desirable Skills

• Degree‑level education or equivalent experience.
• Experience working in a pharmaceuticals, sales or marketing organisation.
• Experience supporting senior stakeholders.
• Knowledge of Veeva Vaults.
• Flexible, proactive and comfortable working independently.
• Strong problem‑solving skills and ability to use initiative.

Why Join Us?

You’ll join a collaborative and supportive team working in an impactful area of the business. This role offers exposure to a wide range of regulatory processes, opportunities to develop new skills and the chance to contribute to the safe and compliant delivery of medicines.

If you’re organised, motivated by helping teams to stay compliant and well-coordinated in a highly regulated environment, we’d love to hear from you.

Date Posted

06-May-2026

Closing Date

20-May-2026

Our 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.