Consultant Regulatory Affairs & Publishing
Location : Hybrid - Madrid or Warsaw

Type : Full-time
We are looking for an experienced Regulatory Affairs professional to join our growing team and play a key role in managing regulatory activities for medicinal products across European markets.
This position offers the opportunity to lead complex regulatory projects, contribute to regulatory strategy, and work closely with cross-functional teams and health authorities to support the successful lifecycle management of our product portfolio.
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
- Lead and manage regulatory submissions, renewals, and post-approval variations for medicinal products across Europe, including National, MRP, DCP, and Centralised Procedures.
- Develop and implement regulatory strategies that support business objectives and ensure compliance throughout the product lifecycle.
- Serve as the regulatory lead for assigned products and provide strategic regulatory guidance to internal stakeholders.
- Assess the regulatory impact of manufacturing, quality, supply chain, and business changes and recommend optimal regulatory pathways.
- Prepare, review, and coordinate regulatory documentation, including Module 1 submissions and eCTD dossiers.
- Manage interactions with European and national Health Au

📌 Consultant Regulatory Affairs (España)
🏢 QbD Group
📍 España