RA Associate at SGS

Mechelen, Antwerp, Belgium -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, Clinical trial applications, Regulatory compliance, Documentation review, Communication, Project coordination, Regulatory strategy, CMC documentation, Clinical protocols, Stakeholder management

Industry

Professional Services

Description

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: 📧 [email protected]

Responsibilities

The RA Associate will coordinate the preparation and submission of regulatory documentation for clinical trials while liaising with Competent Authorities. They will also provide regulatory advice to sponsors and maintain up-to-date knowledge of regional regulatory requirements.