🔍 Consultant Regulatory Affairs & Publishing

📍 Location: Hybrid (Spain or UK)
🕓 Type: Full-time

The QbD Group supports life sciences companies worldwide from idea to patient. QbD’s team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in ATMP, 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 devices

Grow 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 compliance of 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.

💪 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 are

Our 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 us

We 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.