Regulatory Affairs Manager Uk and Ire
2 days ago
Uxbridge
Your new company \nThis leading global biopharmaceutical company is looking for an experienced Regulatory Affairs Manager to join their UK Affiliate Regulatory team on a maternity cover basis. This is a high-impact role working on established products approved via the EMA Centralised Procedure, with strong exposure to post-approval lifecycle activities.\n\nYour new role \nReporting to the Head of UK Regulatory, you will take ownership of one or more products of medium complexity and strategic impact, working closely with UK, Ireland, and EU regulatory stakeholders.Key Responsibilities\n\nLead post-MAA lifecycle management activities for assigned products\nManage complex Type II variations and other regulatory procedures\nSupport and maintain Paediatric Investigation Plans (PIPs)\nContribute to clinical trial regulatory activities as required\nPlan and execute local regulatory submissions in line with EMA, MHRA, and corporate standards.\nProvide local regulatory input into global regulatory strategies\nEnsure product compliance, including IMR, PMCs, and agency commitments\nDevelop and maintain local product labels in line with legislation and internal standards\nReview promotional and non-promotional materials (where in scope)\nAct as the primary point of contact with regulatory authorities\nSupport alignment between local regulatory requirements and global processes\n\nWhat you'll need to succeed \n\nProven experience in UK/EU Regulatory Affairs within pharma or biotech\nStrong background in post-approval regulatory lifecycle management\nDemonstrated experience handling Type II variations\nHands-on experience with PIPs\nExposure to clinical trial regulatory submissions\nFamiliarity with Veeva Regulatory systems (preferred)\nExperience working with centrally approved products via the EMA\n\nWhat you'll get in return \nRemote working\n\nWhat you need to do now\nIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.\nFor more information on this or any other Regulatory Affairs contract jobs, please apply to this advert