Regulatory Affairs Specialist (Life Sciences) job opportunity at Capgemini SE.

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Capgemini SE Regulatory Affairs Specialist (Life Sciences)
Experience: Professional
Pattern: Permanent
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Hiring inbound within Diegem

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.Job DescriptionAs a Regulatory Affairs Specialist focusing on CMC (Chemistry, Manufacturing, and Controls) for vaccines and biological products, you will be responsible for preparing, authoring, and coordinating regulatory submissions throughout the product lifecycle. You will work closely with cross-functional teams to ensure high-quality submissions that meet global regulatory requirements. In this role you will play a key role in:Preparing and coordinating CMC submissions related to lifecycle maintenance of vaccines, including variations, commitments, market expansions, and responses to regulatory authority questionsLiaising with contributing disciplines (QC, QA, Production, Supply) to define technical file content and ensure alignment with regulatory requirementsManaging the planning and organization of regulatory activities in accordance with project timelines and milestonesCompiling and authoring high-quality regulatory documents that meet global regulatory requirements and standardsCoordinating CMC submission file preparation, including change control assessment, source document collection, and management of review processesMaintaining regulatory dossiers and ensuring proper use of regulatory information management systems (Veeva Vault)Your profileBachelor's degree in Life Sciences or equivalent experience, with knowledge of biological products and regulatory proceduresMinimum 3 years of experience in CMC regulatory affairs/Technical Life Cycle Management, preferably with biologicals/vaccinesDemonstrated experience in authoring CMC technical variations and Module 3 components for regulatory submissionsExperience with project management, change control processes, and managing submissions in EU, US, and major regulatory marketsFluent English communication skills (both written and verbal) for daily interaction with global teamsStrong analytical skills with a quality mindset to ensure scientific content accuracy and compliance with regulatory requirements What you'll love about working hereCareer acceleration programs: From associate to leaders and beyond, get support in your career at every stage with award-winning programs such as our leadership development program, Connected Manager, to accelerate your growth and develop your expertise.Worldwide Leader of Engineering Services: Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. We help our clients unleashing their R&D potential to develop smart products and services of tomorrow.Hybrid working: We encourage flexibility when it comes to when and where works gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

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