Regulatory Affairs Associate

hace 3 horas

barcelona, España Inter Regulatory A tiempo completo

Regulatory Affairs Associate (Medicines) Company: Inter Regulatory Employment Type: Full-time About the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub . This role is suited to a regulatory professional with 3–5 years’ experience in pharmaceutical Regulatory Affairs who has hands-on experience authoring regulatory dossiers . The position involves delivering UK, EU, and US regulatory work in a consultancy environment, with a strong focus on CMC documentation and DMF management . Key responsibilities Authoring, reviewing, and maintaining pharmaceutical regulatory dossiers for the UK and EU (CTD / eCTD) Managing CMC documentation for UK and EU regulatory submissions Preparation, maintenance, and lifecycle management of Drug Master Files (DMFs) , including publication and updates Supporting US (FDA) regulatory applications Working closely with internal scientific and quality teams, and with external clients Contributing to the expansion of Inter Regulatory’s pharmaceutical consultancy offering across Europe Required experience and qualifications 3–5 years’ experience in pharmaceutical Regulatory Affairs Proven experience writing regulatory dossiers (essential) (Modules 3 or 4) Strong understanding of CMC regulatory requirements Exposure to UK, EU, and/or US regulatory pathways Degree (or higher) in a scientific discipline or closely related field Fluent English and Spanish , plus ideally a third language Working model Hybrid role Primarily based at the Barcelona Health Hub Part of a growing, distributed European Regulatory Affairs team This role offers hands-on involvement in real regulatory submissions across multiple jurisdictions, broad technical exposure, and the opportunity to grow with a scaling regulatory consultancy rather than a narrow in-house function. You will be joining a small, internatioanl company operating in the US, UK, EU and China. Apply via LinkedIn or contact us directly for more information ( ) #J-18808-Ljbffr

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