RA Associate

Your role In line with our continued growth, we are currently looking for a Regulatory Affairs (RA) Associate to support international clinical trial activities and sponsor interactions. As an RA Associate, you will play a key role in ensuring regulatory compliance and enabling smooth and timely progression of clinical studies across multiple regions. What you will do Coordinate the preparation, review, submission, and follow‑up of regulatory documentation for clinical trials , in close collaboration with Sponsors and study teams Manage clinical trial applications from compilation to submission and approval Liaise with Competent Authorities , addressing questions and providing timely responses Keep Sponsors and internal stakeholders informed on regulatory status and approvals across participating countries Complete and maintain public clinical trial registries , where applicable Gather and maintain up‑to‑date knowledge of country‑specific regulatory requirements using multiple sources (authorities, consultants, online resources, etc.) Advise Sponsors on local regulatory requirements and submission strategies Write and/or review Investigational Medicinal Product Dossiers (IMPDs) and other CMC documentation Perform regulatory review of Investigator’s Brochures and clinical protocols Support and advise on Scientific Advice requests , Agency meetings, and interactions Contribute to the development of Pediatric Investigation Plans (PIPs) , Clinical Development Plans , and PRIME applications

Education & experience A Master’s degree in Pharmaceutical Sciences or Life Sciences At least 1 year of experience in Regulatory Affairs within the pharmaceutical or CRO industry Solid knowledge of EU regulatory procedures Skills & mindset Strong organizational skills with the ability to manage multiple priorities effectively Excellent written and verbal communication skills in English Proven ability to coordinate with cross‑functional teams and meet deadlines A high level of ownership, independence, and accountability Your personality Professional and quality‑driven : you strive for excellence in everything you do Results‑oriented : you take responsibility for outcomes Committed and engaged : you bring focus, passion, and energy to your work Curious and eager to learn : motivated by growth and exposure to a global network Open‑minded and collaborative : you value diverse perspectives and experiences Ambitious : you continuously challenge yourself to improve and excel

What we offer A rewarding international career in an organization known for quality, safety, and integrity The stability and growth of a financially strong global leader Continuous learning alongside top regulatory and scientific experts Opportunities to expand and enrich your career across services, sectors, and regions Strong focus on professional and personal development Exposure to global projects and cross‑border collaboration Ready to take the next step? Are you considering a meaningful next move in your career? This could be it. 👉 Apply via the button and share your story along with your resume. We might soon welcome you as our new colleague—for work, collaboration, and coffee breaks alike. Still have questions? Anneleen will be happy to tell you more: 📧 anneleen.vanbuggenhout@sgs.com