Regulatory Affairs Specialist | Life Sciences

Job Description

As 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 questions
• Liaising with contributing disciplines (QC, QA, Production, Supply) to define technical file content and ensure alignment with regulatory requirements
• Managing the planning and organization of regulatory activities in accordance with project timelines and milestones
• Compiling and authoring high-quality regulatory documents that meet global regulatory requirements and standards
• Coordinating CMC submission file preparation, including change control assessment, source document collection, and management of review processes
• Maintaining regulatory dossiers and ensuring proper use of regulatory information management systems (Veeva Vault)

Your profile

• Bachelor's degree in Life Sciences or equivalent experience, with knowledge of biological products and regulatory procedures
• Minimum 3 years of experience in CMC regulatory affairs/Technical Life Cycle Management, preferably with biologicals/vaccines
• Demonstrated experience in authoring CMC technical variations and Module 3 components for regulatory submissions
• Experience with project management, change control processes, and managing submissions in EU, US, and major regulatory markets
• Fluent English communication skills (both written and verbal) for daily interaction with global teams
• Strong analytical skills with a quality mindset to ensure scientific content accuracy and compliance with regulatory requirements

What you'll love about working here

• Career 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.