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 followup 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 uptodate knowledge of countryspecific 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 Investigators 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 Masters 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 crossfunctional teams and meet deadlines
• A high level of ownership independence and accountability

Your personality

• Professional and qualitydriven: you strive for excellence in everything you do
• Resultsoriented: 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
• Openminded 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 crossborder 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 colleaguefor work collaboration and coffee breaks alike.

Still have questions
Anneleen will be happy to tell you more:

Remote Work :

No

Employment Type :

Full-time