Consultant Regulatory Affairs & PublishingLocation: Hybrid - Madrid or WarsawWe are looking for an experienced Regulatory Affairs professional to join our growing team and play a key role in managing regulatory activities for medicinal products across European markets.This position offers the opportunity to lead complex regulatory projects, contribute to regulatory strategy, and work closely with cross-functional teams and health authorities to support the successful lifecycle management of our product portfolio.What's in it for you?Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devicesGrow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.A fair, competitive package: We offer tailored,



transparent compensation aligned with your expertise, preferences, and local market regulations - because your contribution deserves to be valued.What you'll be doing- Lead and manage regulatory submissions, renewals, and post-approval variations for medicinal products across Europe, including National, MRP, DCP, and Centralised Procedures.- Develop and implement regulatory strategies that support business objectives and ensure compliance throughout the product lifecycle.- Serve as the regulatory lead for assigned products and provide strategic regulatory guidance to internal stakeholders.- Assess the regulatory impact of manufacturing, quality, supply chain, and business changes and recommend optimal regulatory pathways.- Prepare, review, and coordinate regulatory documentation, including Module 1 submissions and eCTD dossiers.- Manage interactions with European and national Health Authorities, including the preparatio

📌 Consultant Regulatory Affairs (Madrid)
🏢 QbD Group
📍 Madrid