Consultant CMC & Regulatory Affairs

QbD Group; Warszawa; Hybrid; PLN 180,000 - 280,000; Full time

Job summary

QbD Group is seeking a Regulatory Affairs professional to support development and registration of medicinal products in a hybrid Warsaw/Madrid/Barcelona setup. You will prepare and deliver CMC documentation for regulatory submissions and advise clients on CMC matters.

You will collaborate with clients and internal teams, ensure regulatory compliance, and contribute to lifecycle management across pharma and biotech projects. Fluent English and independent work style are essential.

Qualifications

• Master's degree in Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related field.
• 4+ years of experience in CMC Regulatory Affairs or related areas.
• Strong knowledge of CMC requirements for development, registration and lifecycle management.
• Fluency in English (written and spoken).
• Excellent communication and organizational skills.
• Ability to work independently and manage multiple activities.

Responsibilities

• Provide solutions and expert support related to development and registration of medicinal products.
• Prepare, review, and deliver CMC documentation for regulatory submissions.
• Support clients in resolving CMC-related matters and respond to Health Authority requests.
• Ensure timely delivery of high-quality projects in compliance with regulatory requirements, scope and budget.
• Collaborate with clients and internal teams to facilitate project execution.
• Provide technical expertise in drug substance and drug product development and lifecycle management for regulatory submissions.
• Review 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.

Skills

CMC Regulatory Affairs

Regulatory submissions

English fluency

Communication

Independent work

Project collaboration

Education

Master's degree in Pharmacy

Job description

Location: Warsaw & Madrid/Barcelona- hybrid work
Type: Full-time

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

• 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.