About this role
CMC Regulatory · Ghent · Hybrid
Technical Writer with focus on Synthetics and/or Biotherapeutics
Turn complex science into clear, submission-ready documents at Ardena, collaborating with experts to support the development of synthetic and biotherapeutic medicines.
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We usually respond within a week
About us
At Ardena, we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world.
As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards.
With more than 750 colleagues across Europe and the United States, Ardena offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill & finish, and CMC regulatory support.
But what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged.
We offer an international environment where you can learn, take initiative, and grow your career across teams, functions, and locations. Our way of working is guided by our CARE values: Communicative, Accountable, Reliable, and Excellent. These values shape how we collaborate, solve challenges, and support each other every day.
At Ardena, you’re not just building your career — you’re helping build the future of medicine.
For the Ardena branch based in Gent, Belgium, our CMC Regulatory Team is looking for a
Technical Writer with focus on Synthetics and/or Biotherapeutics
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 a Technical Writer with focus on Synthetics and/or Biotherapeutics, you will play a key role in supporting process development by preparing high-quality technical documentation. This position offers an excellent opportunity to collaborate with experienced professionals and gain hands-on exposure to the dynamic and fast-evolving pharmaceutical field.
Key Responsibilities
Support the development, coordination and, where appropriate, authoring and compiling scientific and technical documentation related to the development of synthetic and biotherapeutics, including:
ICH M7 Nitrosamine Risk Assessments
Criticality Analyses
Process Development Reports
Investigation reports
Other supporting documents for global regulatory submissions
Establish and maintain project workplans
Coordinate cross-functional Subject Matter Experts
Track actions, dependencies and timelines and drive documentation through review and approval
Ensure documents comply with current ICH and other applicable regulatory guidelines
Ensure high-quality documentation and discuss potential issues with the customer
Your Profile
Education & Interests
Ph.D. in Pharmaceutical Sciences, Biotechnology, Bioengineering, or a related life sciences field, or equivalent relevant professional experience.
Strong interest in drug development, regulatory science, and technical/scientific writing for chemical and biological products
Skills & Competencies
Team player
Excellent written and verbal communication skills
Fluency in English (both written and spoken)
Proficiency in MS Office (particularly Word and Excel)
Strong technical writing and documentation skills with keen attention to detail
Highly organized, with the ability to prioritize and adapt in a dynamic environment
Independent, proactive, and eager to learn
Analytical mindset with problem-solving skills and a strong quality focus
AI savviness is a must!
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 with extra-legal benefits such as meal vouchers and group/hospitalization insurance.
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, Tel: +32 (0) 9 267 65 00.
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in Belgium) will not be given a status update.
Agency calls will not be appreciated.
Department
CMC Regulatory
Role
CMC writer/ Regulatory officer
Location
Ghent
Remote status
Hybrid
Contact Vicky De Paepe HR Manager – Human Resources
Colleagues
Anke Moret
Director CMC Regulatory
Julie De Smet
Director Dossier Development
Sebastiaan Colenbie
Senior CMC Writer
Lieselotte Veryser
Senior CMC Writer
Tessa Vermeire
Senior CMC Writer
Tibbe Dhooge
CMC Writer
Leonie Lust
Associate CMC Writer
Ellen Verschaere
CMC Writer
Kelly Van Looveren
Senior CMC Writer
Luna Van Wambeke
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CMC Regulatory · Ghent · Hybrid
Technical Writer with focus on Synthetics and/or Biotherapeutics
Turn complex science into clear, submission-ready documents at Ardena, collaborating with experts to support the development of synthetic and biotherapeutic medicines.
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