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.

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.

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.

Consultant, Regulatory Affairs & Publishing

Key skills