Consultant CMC & Regulatory Affairs

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.

• 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.

• Masters 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.

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.

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no non-sense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre serious about your work but not too serious about yourself

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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.