Consultant CMC & Regulatory Affairs

📍 Location: Warsaw - hybrid work

🕓 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.

💪 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.