Consultant Regulatory Affairs & Publishing

Consultant Regulatory Affairs & Publishing

The [Employer hidden — view at passion-project.co.uk] Group supports life sciences companies worldwide from idea to patient. [Employer hidden]’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. [Employer hidden] 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 [Employer hidden] family.