Hybrid Consultant, Regulatory Affairs & Publishing

at QbD Group

• Job title: Consultant, Regulatory Affairs & Publishing
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Madrid, Spain

About the role

• Consultant Regulatory Affairs supporting medicinal product registrations in EU and UK. Managing compliance documentation, communicating with Regulatory Authorities, and updating product information.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• 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.