Consultant CMC & Regulatory Affairs

TRIUM Clinical Consulting NV; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

TRIUM Clinical Consulting NV is seeking a CMC Regulatory Affairs specialist to support development, registration, and lifecycle management of medicinal products across Warsaw and Madrid/Barcelona in a hybrid setup. You will combine CMC expertise with client-facing consulting to drive regulatory submissions and GMP documentation.

The role emphasizes delivering high-quality, compliant documentation, resolving CMC questions from Health Authorities, and collaborating with clients and internal teams

Qualifications

• Master's degree in Pharmacy or related field.
• Minimum 4 years of experience in CMC Regulatory Affairs or related area.
• Strong knowledge of CMC requirements for development, registration, and lifecycle management of medicinal products.
• Fluency in English (written and spoken).

Responsibilities

• 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.

Skills

English fluency

Communication skills

Organizational skills

Problem solving

Independent worker

Curiosity

No-nonsense approach

Innovative

Education

Master's degree in Pharmacy/related field

Job description

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 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.