Regulatory Affairs Assistant

Job Title: Regulatory Affairs Assistant

Location:Pancras Square, UK

Introduction to the Role

We’relooking for aRegulatory Affairs Assistantto join our Medical and Scientific Affairs Directorate. In this role,you’llprovideadministrative, operational and compliance support to the Head of Regulatory and the wider Regulatory Affairs team, helping tomaintainaccuratedata and documentation, support team processes and ensure activities are delivered efficiently in a regulated environment.

This isa great opportunityfor someonewho is highly organised, proactive and detail focused;with experience in regulatory, compliance or quality environments, andwho is ready to grow their skills in a supportive,fast‑pacedand highly regulated setting.

The ideal person will enjoy enabling others, taking ownership of key support activities,identifyingopportunities to improve how the roleoperates, and developing enough understanding of regulatory language and context to work confidentlyto support a team of Regulatoryprofressionals.

WhatYou’llDo

You’llprovide administrative, operational and compliance support to the Regulatory Affairs team, helping to ensure our products, documentation and internal processesremainaccurate,well managedand compliant.

You’llwork 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

• Assistwith compiling regulatoryfiles andsupport product registrationandlicence maintenanceactivities.

• Maintaining databases, supporting clinical documentation archiving and qualitychecksand uploading documents tointernal and externalplatforms (e.g.VeevaVault,eMC).

• Maintain regulatory and technical archives, ensuring documentation is audit ready and accurately tracked.

• AssistRegulatory team memberswith global and regional submission plans forallocatedproducts and projects.

• Coordinate simple submissions such as parallel import applications orFreedom ofInforation(FOI)responses.

• Update templates, coordinateteam trainingactivitiesandmaintainstatus‑trackingmaterials.

• Prepare and share reports on key metrics, overdue activities, issues,actionsand risks(e.g. Quality Events (QE’s).

Administrative Support to the Head of Department & Regulatory Team

• Support finance‑related activities including budgettracking, invoicemonitoring, annual feepaymentsand cross‑chargingactivities.

• Raise and track purchase orders in Coupa, ensuringtimelyprocessing ofsupplier 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 andmaintainaccuraterecords.

• Coordinate training activities, update trainingmatricesandmaintaindocumentation.

• Maintain departmental distribution lists, organisation charts, planningcalendarsand product responsibility lists.

• Develop and improveadministrative systems andways of working.

• Organise meetings, onboarding and offboarding activities, teameventsand other departmentallogistics.

• Produceaccuratedocumentation including minutes, agendas,reportsand presentations.

• Provide inbox cover for the regulatory mailbox during absences.

Essential Skills & Experience

• Experience working in regulatory, compliance or quality departments.

• Strong understanding of localSOPs,codesand 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‑leveleducation or equivalent experience.

• Experience working in apharmaceuticals,salesormarketing organisation.

• Experience supporting senior stakeholders.

• Knowledge of Veeva Vaults.

• Flexible,proactiveand comfortable working independently.

• Strongproblem‑solvingskills and ability to use initiative.

Why Join Us?

You’lljoin 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.

Ifyou’reorganised, motivatedby helping teams to stay compliant and well-coordinated in a highly regulated environment,we’dlove to hear from you.