CMC Writer CMC Regulatory · Ghent ·

Ardena; Oost-Vlaanderen; Hybrid; EUR 55,000 - 90,000; Full time

Benefits offered by this job

Meal vouchers

Group/hospitalization insurance

Flexible working hours

Partial telework

32 days annual leave

Job summary

Ardena in Gent, Belgium, seeks an (Associate) Scientific Writer – CMC Drug Substance to contribute to drug substance process development. You will craft technical documents and support regulatory submissions with cross-team collaboration.

The role offers exposure to cutting-edge chemical and biological development, regulatory guidance, and a dynamic, international work environment with flexible hours.

Qualifications

• 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.
• Fluent in written and spoken English.

Responsibilities

• Write and compile scientific and technical documents for drug substance development.
• Coordinate writing and reviews across CMC activities.
• Ensure alignment with ICH guidelines and up-to-date regulatory standards.
• Manage projects and timelines for technical writing tasks.

Skills

Strong scientific writing

Very good communication

Fluent English

Attention to detail

Independent work

Problem solving

AI savviness

Education

Master’s or PhD in chemistry/biotech

Tools

MS Office (Word, Excel)

Job description

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 trialapplications, 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.

For more information about the role, please contact HR.

Email: [e-mail], Tel: [phone].

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.