Senior Regulatory Affairs Associate, EU & UK Market

Reference: Job ID: Posted: Closing date: Location: LondonSalary: Competitive Salary (per annum)Job type: PermanentWorking pattern: Full timeIndustry: Pharmaceuticals / Regulatory AffairsCompany: HaysConsultant: Alex SpeakmanHays office: London-City — 5th Floor, 107 Cheapside,Phone: Email: new companyAn established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development.Your new roleAs a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact.What you'll need to succeedDegree in Life Sciences, Pharmacy, or a related fieldProven Regulatory Affairs experience within the pharmaceutical industry (generics preferred)Strong knowledge of UK (MHRA) and EU regulatory frameworksExperience with CTD/eCTD submissions and lifecycle managementFamiliarity with variations and post-approval processesExcellent organisational and communication skillsAbility to manage multiple projects in a fast-paced environmentWhat you'll get in returnHybrid working (3 days onsite in London, 2 days remote)Opportunity to work within a collaborative and supportive teamExposure to a broad and varied generics portfolio across UK and EU marketsCareer development and ongoing training opportunitiesWhat you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. # - Alex Speakman