About this role
📍 Location : Warsaw & Madrid/Barcelona– hybrid work
đź•“ Type : Full-time
Join our CMC Regulatory Affairs team and work on complex projects supporting the development, registration, and lifecycle management of medicinal products.
You will combine your CMC expertise with client-facing consulting, supporting regulatory submissions, pharmaceutical development, GMP documentation, and Health Authority interactions.
🏢 What you’ll be doing
- Provide solutions and expert support related to the development and registration of medicinal products.
- Prepare, review, and deliver CMC documentation for regulatory submissions covering both development-stage and commercial products.
- Support clients in resolving CMC-related matters and responding to Health Authority questions and requests.
- Ensure the timely delivery of high-quality projects in compliance with regulatory requirements, agreed scope, and budget.
- Collaborate closely with clients and internal teams to facilitate the successful execution of projects.
- Provide technical expertise in drug substance and drug product development and lifecycle management, supporting regulatory submissions throughout the product lifecycle, including clinical development, marketing authorization, and post-approval variations.
- Review and work with GMP documentation related to manufacturing sites for medicinal products.
- Verify manufacturing documentation, including batch records.
- Participate in projects involving pharmaceutical development, regulatory submissions, and lifecycle management activities.
đź’Ş What you bring
- Master's degree in Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related field.
- Minimum 4 years of experience in CMC Regulatory Affairs, pharmaceutical development, manufacturing, quality assurance, or a related area.
- Strong knowledge of CMC requirements for the development, registration, and lifecycle management of medicinal products.
- Fluency in English, both written and spoken.
- Excellent communication and organizational skills, with the ability to prioritize and manage multiple activities effectively.
- Strong problem-solving skills, accountability, and the ability to work independently.
💡 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.
🫵 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 700 experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma. Since January 2025, SciencePharma has been part of QbD Group, joining forces to deliver comprehensive end-to-end solutions.
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.