Consultant Regulatory Affairs & Publishing

🔍 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.

💡 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 Authorities, including the preparation of responses to regulatory questions and deficiency letters.

• Oversee eCTD publishing and electronic submissions through applicable submission platforms.

• Ensure compliance and maintenance of product information, including SmPC, PIL, and packaging artwork.

• Monitor and interpret evolving regulatory requirements and assess their impact on the company's product portfolio.

• Support continuous improvement initiatives within Regulatory Affairs processes and systems.

• Mentor and provide guidance to junior team members, sharing expertise and best practices across the organization.

💪 What you bring

• University degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.

• Minimum 6-8 years of Regulatory Affairs experience within the pharmaceutical industry.

• Proven experience independently managing regulatory procedures, including variations, renewals, and marketing authorization applications.

• Strong knowledge of EU pharmaceutical legislation and regulatory requirements.

• Hands-on experience with National, MRP, DCP, and/or Centralised Procedures.

• Demonstrated experience in regulatory strategy development and lifecycle management.

• Solid knowledge of CTD/eCTD dossier structure and submission requirements.

• Experience with electronic submission platforms such as CESP, EMA Gateway, or equivalent.

• Experience communicating directly with regulatory authorities and managing regulatory queries.

• Strong project management skills with the ability to manage multiple priorities in a dynamic environment.

• Excellent analytical, organizational, and problem-solving skills.

• Strong stakeholder management and communication skills.

🫵 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 QbD family.