🔍 Consultant Regulatory Affairs & Publishing📍 Location: Hybrid (Spain or UK)🕓 Type: Full-timeThe QbD Group supports life sciences companies worldwide from idea to patient. QbD’s team offersknowledge&tailored (software) solutionsin development, clinical, regulatory & compliance, production and distribution for companies active inATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health and Pharma.QbD has affiliates in 8 different countries and can count on the expertise of more than 500 life science professionals and growing.💡 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- Supervision and conducting of registration, renewal, and variation procedures for medicinal products in the EU countries (via DCP/MRP and Centralized procedures) and for the United Kingdom;
active communication with Regulatory Authorities;
- Preparation of the administrative part of the documentation (module 1);
completion of the registrations, renewals, and variations documentation for medicinal products (including classification of variations) and planning of the procedure strategy;
- Publication of eCTD sequences;
- Audits of the administrative part of the product documentation (module 1);
- Maintaining complianceof registration documentation with regulatory requirements in EU countries;
- Participation in the preparation and updating of Product Information (SmPC, package leaflet, packaging labeling) for medicinal products.- Preparation of translations of Product Information (SmPC, package leaflet, packaging labeling) for medicinal products;
- Verifying mock-ups of labelling/patient leaflet;
- Preparing and submitting applications for the sunset clause exemption;
- Preparing and conducting Marketing Authorisation Holder transfers.đź’Ş What you bring- Higher education in pharmacy, medicine, chemistry, or a related field;
- Experience in preparing registration, renewal and variations documentation (Module 1);
- Experience in working with Product Information;
- Ability to submit documentation to Regulatory Authorities via electronic gateways (CESP, EMA Gateway);
- Experience in preparing documentation in eCTD format;
- Very good, practical knowledge of spoken and written English;
- Highly developed communication skills and ease in formulating thoughts and conclusions, also in writing.- Very good organization of own work;
- Meticulousness in performing tasks;
- Willingness to continuously improve one's competences.🫵 Who you areOur culture is driven by values If this sounds like you, you’ll fit right in:- You’re resilient and tackle challenges with a positive mindset- You’re curious and always up for learning something new- You have a no non-sense approach honest, clear, respectful- You’re innovative and bring ideas, not just opinions- And above all, you’re serious about your work, but not too serious about yourself✨ About usWe support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.We believe in JPEG:Joy. Partnership. Going the Extra Mile. Getting Things Done.You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.📩 Interested? Let’s talk.Send us your CV and motivation letter. You could be the next one to join the QbD family.#J-18808-Ljbffr