Consultant CMC & Regulatory Affairs

SciencePharma; Warszawa; On-site; PLN 180,000 - 280,000; Full time

Job summary

SciencePharma's CMC Regulatory Affairs team seeks a skilled professional to support development, registration, and lifecycle management of medicinal products. You will prepare and review CMC documentation for regulatory submissions across development and commercial products, interact with Health Authorities, and ensure GMP documentation compliance.

English fluency and a strong track record of 4+ years in CMC regulatory affairs are essential as you collaborate with clients and internal teams on

Qualifications

• Minimum 4 years of experience in CMC Regulatory Affairs, pharmaceutical development, manufacturing, quality assurance, or related area.
• Strong knowledge of CMC requirements for development, registration and lifecycle management of medicinal products.
• Fluency in English, both 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 timely delivery of high-quality projects in compliance with regulatory requirements, scope and budget.
• Collaborate with clients and internal teams to facilitate successful project execution.
• Provide technical expertise in drug substance and drug product development and lifecycle management across the product lifecycle, including clinical development, MA, and post-approval variations.
• 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 activities.

Skills

CMC Regulatory Affairs

Regulatory submissions

English fluency

Project management

Education

Master's degree in Pharmacy

Job description

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

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.