About us

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services. 
The Ardena Group is operating from five sites in Europe and one in US. 

For the Ardena branch based in Gent, Belgium, our CMC Regulatory Team is looking for an

Associate CMC Regulatory Data Specialist (entry-level role)

The CMC Regulatory team is dedicated to delivering customized and timely regulatory drug development services to our valued customers. Our support spans all aspects of Chemistry, Manufacturing & Control (CMC) writing activities across various stages of the drug development process. We collaborate closely with other Ardena teams, providing CMC advice throughout drug development and dossier submission.

Position Overview:

As an Associate CMC Regulatory Data Specialist, you combine a passion for science with a strong interest in data systems and process management. Ideally, you have a scientific background and a basic understanding of eCTD structures, along with solid PC skills and an eye for detail. You enjoy working with data and are comfortable maintaining and improving information management systems.

In this role, you will support our customers by ensuring the accuracy, completeness, and quality of their CMC regulatory data within various systems and databases. You’ll collaborate closely with experienced regulatory professionals, gaining hands-on experience in the evolving field of regulatory information and data management. This is an excellent opportunity to grow your expertise at the intersection of science, data, and regulatory compliance.

Key Responsibilities:

• Keep regulatory data accurate and consistent in the Regulatory Information Management (RIM) system — including cleaning up, updating, and checking data against approved CMC documents.
• Compare and reconcile information across systems (databases, Excel reports, and source documents).
• Coordinate review and approval steps across different projects.
• Work with product leads and other team members to ensure alignment and data quality.
• Track timelines and help make sure projects stay on schedule.
• Deliver high-quality data input and flag potential issues early to customers.

Your Profile:

Education and Interest:

• You hold a Master’s degree in a scientific discipline (such as chemistry, pharmacy, biology, or a related field).
• You have a genuine interest in regulatory data, systems, and processes — and enjoy seeing how data supports real-world science.
• A basic understanding of the eCTD structure (especially Module 3) is a definite plus.

Skills & Competencies:

• Strong attention to detail — you like getting things right and keeping data clean and consistent.
• Comfortable working with MS Office, especially Excel pivot tables.
• Familiarity with data management systems is an advantage, but not a must — curiosity and willingness to learn matter more.
• Excellent communication skills, both written and spoken.
• Fluent in English, with the ability to communicate clearly across teams and cultures.
• Highly organized, able to prioritize and stay on top of multiple tasks in a dynamic environment.
• Independent and proactive, with a strong drive to learn.
• A naturally analytical thinker, with problem-solving skills and a strong focus on quality and accuracy.

What We Offer:

• Opportunity to contribute to the development of new drugs.
  
• A supportive learning environment for skill development and growth.
  
• Involvement in a rapidly growing international company with an intriguing services, product, and customer portfolio.
  
• Dynamic working environment with friendly and collaborative colleagues.
  
• Open, straightforward, and caring company culture.
  
• Attractive remuneration package.
  
• Flexible working hours and the possibility for partial telework.
  
• Generous annual leave entitlement of 32 days.

Join us in shaping the future of drug development and be part of a team that values your contributions and personal growth. Apply now and embark on an exciting journey with us!

Ready to apply? Please click on the application button

For more information about the role, please contact HR.

Email: HR@ardena.com