Regulatory Affairs Assistant

Job Title: Regulatory Affairs Assistant

Location:Pancras Square UK

Introduction to the Role

Werelooking for aRegulatory Affairs Assistantto join our Medical and Scientific Affairs this roleyoullprovideadministrative 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 supportivefastpacedand highly regulated setting.

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

WhatYoullDo

Youllprovide administrative operational and compliance support to the Regulatory Affairs team helping to ensure our products documentation and internal processesremainaccuratewell managedand compliant.

Youllwork across a broad range of activities includingregulatory support data and document management project coordination reporting and team administration always ensuring alignment withGood Regulatory Practice (GRP) requirements theQuality 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.VeevaVaulteMC).

• 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 trainingactivitiesandmaintainstatustrackingmaterials.

• Prepare and share reports on key metrics overdue activities issuesactionsand risks(e.g. Quality Events (QEs).

Administrative Support to the Head of Department & Regulatory Team

• Support financerelated activities including budgettracking invoicemonitoring annual feepaymentsand crosschargingactivities.

• 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 agendasreportsand presentations.

• Provide inbox cover for the regulatory mailbox during absences.

Essential Skills & Experience

• Experience working in regulatory compliance or quality departments.

• Strong understanding of localSOPscodesand 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

• Degreeleveleducation or equivalent experience.

• Experience working in apharmaceuticalssalesormarketing organisation.

• Experience supporting senior stakeholders.

• Knowledge of Veeva Vaults.

• Flexibleproactiveand comfortable working independently.

• Strongproblemsolvingskills and ability to use initiative.

Why Join Us

Youlljoin 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.

Ifyoureorganised motivatedby helping teams to stay compliant and well-coordinated in a highly regulated environmentwedlove to hear from you.