About this role
CMC Regulatory · Ghent · Hybrid
(Associate) Scientific Writer – CMC Drug Substance
Turn complex drug substance science into clear regulatory documents at Ardena, supporting the development of new medicines while growing your CMC writing expertise.
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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
(Associate) Scientific Writer – CMC Drug Substance
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 (Associate) Scientific Writer – CMC Drug Substance, you will play a pivotal role in the drug substance process development by contributing to the creation of qualitative documents. This position offers a fantastic opportunity to collaborate with experienced colleagues and gain firsthand experience in the dynamic drug substance field.
Key Responsibilities
Write and compile scientific and technical documents related to the drug substance development of both new chemical entities and biological products, such as:
synthesis criticality assessments
starting material justification reports
impurity management reports
documents related to upscaling of the synthesis process
etc.
These documents may be used as basis for global regulatory submissions (clinical trial applications, marketing applications, etc.)
Establishing the control strategy for the drug substance manufacturing (specifications)
Nitrosamine and mutagenicity assessments per ICH M7
Alignment of the documents to ensure compliance with the latest ICH guidelines
Project management/coordination of technical writing and reviewing activities
Your Profile
Education and Interest
Master’s degree or Ph.D. in chemistry or biotechnology.
Affinity with organic chemistry and drug substance development is a plus.
Passion for scientific and technical writing for chemical and biopharmaceutical products.
Strong interest in drug development and regulatory guidelines.
General Skills
Proficient in MS Office (primarily Word and Excel.
Very good communication skills (both written and spoken).
Fluent in written and spoken English.
Strong scientific writing skills.
Attention to detail and accuracy.
Eager to learn and ability to work independently when necessary.
Problem-solving skills with a quality-conscious attitude.
Well-organized with the ability to work in a dynamic environment.
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
Opportunities
Technical Writer with focus on Synthetics and/or Biotherapeutics CMC Regulatory · Ghent · Hybrid
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CMC Regulatory · Ghent · Hybrid
(Associate) Scientific Writer – CMC Drug Substance
Turn complex drug substance science into clear regulatory documents at Ardena, supporting the development of new medicines while growing your CMC writing expertise.
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