RA Associate

Description du poste:

Company Description:

Build a career that truly makes an impact.
At SGS, the world's leading testing, inspection, and certification company, you don't just have a job-you contribute to making the world safer, more sustainable, and more connected. With over 140 years of heritage, Swiss roots, and a strong global presence, we offer the stability of an industry leader combined with the energy of continuous growth and innovation.
Join a global, multicultural organization where knowledge is shared across borders, expertise runs deep, and your professional development is a priority. Here, you will find the space to grow, learn, and reach your full potential-while collaborating with some of the best experts in the industry.

Job Description:

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

Qualifications:

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

Additional Information:

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