Title: Regulatory Affairs OfficerCompany: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.K, we tackle areas of high unmet medical need through research and innovation. For more information, visit us at and follow our latest news on LinkedInand Instagram. Regulatory Affairs Officer Location: Paddington, London (Hybrid Working)Department: Medical & Regulatory Affairs, UK & IrelandAbout IpsenAt Ipsen, we are committed to improving the lives of patients through innovative medicines in areas of significant unmet need. The OpportunityWe are seeking a Regulatory Affairs Officer to join our UK & Ireland Medical and Regulatory Affairs team. This role offers broad exposure across Regulatory Affairs, Quality and Compliance, supporting both marketed and pipeline products, with a strong focus on our oncology portfolio. Reporting to the Senior Regulatory Affairs Manager, you will play an important role in ensuring regulatory compliance, supporting licence maintenance activities and helping to bring innovative medicines to healthcare professionals and patients, with an initial focus in our oncology portfolio. Key ResponsibilitiesRegulatory AffairsSupport the preparation and submission of regulatory lifecycle maintenance activities in the UK and Ireland. Coordinate and implement approved regulatory changes, including updates to SmPCs, PILs, labels and packaging materials. Support responses to requests from regulatory authorities, including the MHRA and HPRA.Maintain regulatory databases, submission trackers and document management systems. Work closely with Global Regulatory Affairs and cross-functional stakeholders to support regulatory strategy and execution. Regulatory IntelligenceMonitor and communicate developments within the UK and Irish regulatory environment. Conduct competitor intelligence activities and monitor regulatory developments within oncology. Support the assessment of regulatory changes that may impact the business and patients. Compliance & QualityEnsure all activities are conducted in accordance with applicable regulatory requirements, GxP standards and company procedures. Support controlled document management and quality systems activities. Assist with change controls, deviations, CAPAs and inspection readiness initiatives. Support complaint administration and investigation activities as required. Contribute to compliance reporting and KPI generation. Cross-Functional CollaborationPartner with colleagues across Medical Affairs, Pharmacovigilance, Quality, Supply Chain, Commercial and Global Regulatory Affairs teams. Support continuous improvement initiatives within the Regulatory Affairs and Quality function. Help maintain a culture of compliance, quality and patient focus. About YouEssential RequirementsDegree in Life Sciences or a related scientific discipline. Experience working within the pharmaceutical industry. Understanding of the UK medicines regulatory framework. Strong organisational and project management skills. Strong attention to detail and commitment to quality. Experience with Regulatory Operations activities. Experience working with Quality Management Systems. Knowledge of quality processes, including deviations, CAPAs and change controls. What We're Looking ForThe successful candidate will be a proactive, collaborative and detail-oriented regulatory professional who enjoys working in a fast-paced environment. You will be comfortable building relationships across functions, managing competing priorities and ensuring activities are delivered to a high standard. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. SummaryLocation: London (UK)Type: Full time
Regulatory Affairs Officer - Pharmaceuticals in London employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer that prioritises a human-centric workplace culture, fostering collaboration and excellence. With a commitment to employee growth, Ipsen offers opportunities for continuous improvement and innovation in the biopharmaceutical field, particularly in vibrant locations like Paris and London. Employees are empowered to thrive, making a meaningful impact on patients and society while enjoying a supportive environment that values diverse perspectives.
