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ClosedPosted 32 days ago

Consultant CMC & Regulatory Affairs

qbdbv34 open roles

Where
Warszawa, Poland; Rubí, Spain; Pozuelo de Alarcón, Spain
Work mode
Hybrid

This posting closed on 2026-10-02. 34 other qbdbv postings are live.

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Still open, like this oneLive
  1. Validation and Qualification Engineer11h agoqbdbv · Antwerpen, Belgium; Charleroi, Belgium
  2. Qualification and Validation Specialist (The Netherlands)11h agoqbdbv · Breda, Netherlands
  3. Quality Management Specialist11h agoqbdbv · Charleroi, Belgium; Antwerpen, Belgium; Rubí, Spain; Pozuelo de Alarcón, Spain
  4. Computer System Validation (CSV) Specialist11h agoqbdbv · Rubí, Spain; Charleroi, Belgium; Antwerpen, Belgium

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market. qbdbv postings stay open a median of 1 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 32 days ago

qbdbv median: 1 days open

The posting

📍 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.

📩 Interested? Let’s talk. Send us your CV and motivation letter. You could be the next one to join the QbD family.

Posting text belongs to the employer. Removal requests: contact us.

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