Ardena Careers

About the Company

Find your career path with Ardena

At Ardena, we’re more than a global Contract Development and Manufacturing Organization (CDMO)—we’re a team of innovators, problem-solvers, and experts dedicated to advancing drug development. With over 750 professionals across Belgium, the Netherlands, Sweden, Spain, and the US, we help biopharma companies navigate complex challenges and bring new therapies to patients.

Whether you’re a scientist, engineer, project manager, or business professional, Ardena offers dynamic career opportunities, global collaboration, and a people-first CARE culture where you can grow, innovate, and make a real impact. Join us and together, we’ll transform your potential—and the future of medicine!

When you join Ardena, you gain:
Diverse Projects – Work on breakthrough therapies across a range of customers and drug types.
Global Collaboration – Connect with colleagues across Belgium, the Netherlands, Sweden, Spain, and the US.
Comprehensive Training – Benefit from our Ardena Academy, onboarding programs, and ongoing career development.
Career Growth – Advance your skills with mentorship, learning opportunities, and leadership pathways.
A People-First Culture – Enjoy a supportive, international work environment that values collaboration and innovation.
At Ardena, your career growth knows no limits. Whether you’re starting with an internship, joining as an experienced professional, or looking to expand your expertise, we provide the tools, support, and opportunities to help you succeed.

Ready to start your career path with Ardena? Explore our careers: https://careers.ardena.com/

Listed Jobs

Company Name

Ardena Careers

Job Title

Associate CMC Regulatory Data Specialist (entry-level role)

Job Description

**Job Title** Associate CMC Regulatory Data Specialist (Entry-Level) **Role Summary** Entry‑level specialist supporting the CMC Regulatory team by ensuring accurate, complete and compliant regulatory data across internal systems. Works closely with regulatory professionals to manage, reconcile and maintain CMC information for drug development dossiers, coordinating reviews and approvals. **Expectations** - Maintain high data integrity and document compliance in the Regulatory Information Management (RIM) system. - Reconcile information between databases, spreadsheets and source documents. - Coordinate review cycles, track timelines and provide early issue escalation. - Exhibit strong analytical judgment, detail orientation and proactive problem‑solving. - Communicate clearly in English, collaborating across cross‑functional teams. **Key Responsibilities** - Update, clean and validate regulatory data within RIM, aligning with approved CMC documents. - Reconcile CMC data across multiple systems (databases, Excel reports, source files). - Coordinate review and approval steps across projects, ensuring milestones are met. - Partner with product leads and colleagues to verify data accuracy and consistency. - Monitor project timelines, report progress and flag potential compliance issues. - Deliver high‑quality data entry and support the regulatory submission process. **Required Skills** - Strong attention to detail and data quality focus. - Proficient in MS Office, especially Excel (pivot tables, data manipulation). - Excellent written and verbal communication in English. - Highly organized, able to prioritize multiple tasks in a dynamic environment. - Independent, proactive, and eager to learn new data management systems. - Analytical thinker with problem‑solving and quality‑centric mindset. **Required Education & Certifications** - Master’s degree in chemistry, pharmacy, biology or related scientific discipline (or equivalent). - Basic understanding of eCTD structure (Module 3) preferred. - No mandatory certifications, but willingness to obtain regulatory data management training is an advantage.

Ghent, Belgium

Hybrid

05-11-2025