Regulatory Affairs Jobs at Capgemini in Belgium
Looking to advance your career in regulatory affairs jobs within the life sciences sector? This opportunity as a regulatory affairs specialist at Capgemini Engineering offers hands-on exposure to vaccines and biological products while working with global regulatory authorities. Based in Europe, this role is ideal for professionals and graduates seeking Jobs in Belgium and a long-term Job Opportunity for life science students aiming to build expertise in regulatory compliance and CMC submissions.
About Capgemini Engineering
Capgemini Engineering is a global leader delivering cutting-edge engineering and R&D services. With over 340,000 professionals worldwide, jobs at Capgemini span digital transformation, life sciences, AI, and sustainable innovation. The company’s strong European presence makes it a top destination for Jobs in Belgium and international regulatory professionals.
Job Details:
- Job Title: Regulatory Affairs Specialist (Life Sciences – CMC)
- Company: Capgemini Engineering
- Industry: Life Sciences / Engineering Services
- Work Model: Hybrid
Regulatory Affairs Job Overview
As a Regulatory Affairs Specialist with a focus on CMC (Chemistry, Manufacturing, and Controls) for vaccines and biological products, you will be responsible for preparing, authoring, and coordinating regulatory submissions across the product lifecycle. You will collaborate with cross-functional teams to ensure high-quality, compliant submissions that meet global regulatory requirements.
Key Responsibilities:
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Prepare and coordinate CMC submissions related to the lifecycle maintenance of vaccines, including variations, commitments, market expansions, and responses to regulatory authority questions.
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Liaise with contributing disciplines (QC, QA, Production, Supply) to define technical file content and ensure regulatory compliance.
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Manage the planning and organization of regulatory activities according to project timelines and milestones.
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Compile and author high-quality regulatory documents in compliance with global requirements and standards.
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Coordinate CMC submission file preparation, including change control assessment, source document collection, and review process management.
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Maintain regulatory dossiers and ensure proper use of regulatory information management systems (e.g., Veeva Vault).
Your Profile for Regulatory Affairs Job
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Bachelor’s degree in Life Sciences or equivalent experience, with knowledge of biological products and regulatory procedures.
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Minimum of 3 years of experience in CMC regulatory affairs/Technical Life Cycle Management, preferably with biologicals or vaccines.
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Experience authoring CMC technical variations and Module 3 components for regulatory submissions.
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Familiarity with project management, change control processes, and managing submissions in EU, US, and other major regulatory markets.
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Fluent in English (written and verbal) for daily interaction with global teams.
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Strong analytical skills and a quality mindset to ensure scientific content accuracy and regulatory compliance.
What You’ll Love
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Career Acceleration Programs: Grow your career with award-winning programs like our Leadership Development Program and Connected Manager initiatives.
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Worldwide Leader in Engineering Services: Leverage our deep industry knowledge and cutting-edge digital and software technologies to support the convergence of physical and digital worlds.
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Hybrid Working: Flexible work arrangements tailored to your role and personal circumstances.
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Global Impact: Join a diverse team of 340,000+ members in more than 50 countries, helping organizations accelerate their dual transition to a digital and sustainable world.
