Consultant Regulatory Affairs & PublishingLocation : Hybrid (Spain or UK)Type : Full-time
The 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 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 submitdocumentation 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 inperforming 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