? Location: Warsaw & Madrid/Barcelona– 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 or

📌 Consultant CMC (Rubí)
🏢 QbD Group
📍 Rubí