Consultant Regulatory Affairs & Publishing
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Job Location:
Pozuelo de Alarcón - Spain
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Consultant Regulatory Affairs & Publishing
Location: Hybrid (Spain or UK)
Type: Full-time
The QbD Group supports life sciences companies worldwide from idea to patient. QbDs 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.
Whats 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 youll 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 ones competences.
Who you are
Our culture is driven by values If this sounds like you youll fit right in:
Youre resilient and tackle challenges with a positive mindset
Youre curious and always up for learning something new
You have a no non-sense approach honest clear respectful
Youre innovative and bring ideas not just opinions
And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.
Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.
