Technical Writer MSAT CMC Regulatory · Ghent ·

Ardena; Oost-Vlaanderen; Hybrid; EUR 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Meal vouchers

Group/hospitalization insurance

Flexible working hours

Partial telework

32 days annual leave

Zusammenfassung

Ardena is seeking a Technical Writer with a focus on synthetics and/or biotherapeutics at our Gent, Belgium site. The role supports CMC regulatory writing with high-quality documentation and collaboration across teams to enable timely submissions.

You will contribute to ICH-compliant material, coordinate with SMEs, and help ensure deliverables meet regulatory standards while advancing drug development programs.

Qualifikationen

• 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 writing for chemical and biological products.

Aufgaben

• Support development, coordination and authoring of scientific/technical documentation related to synthetic and biotherapeutics.
• Prepare ICH M7 Nitrosamine risk assessments and other regulatory documents.
• Create Criticality Analyses and Process Development Reports.
• Draft investigation and submission documents for global regulatory filings.
• Establish and maintain project workplans and timelines.
• Coordinate cross-functional Subject Matter Experts.
• Track actions and drive review/approval processes.
• Ensure documents comply with ICH and regulatory guidelines.
• Maintain high-quality documentation and discuss issues with customers.

Kenntnisse

Team player

Excellent written and verbal comms

Fluency in English

MS Office (Word/Excel)

Strong technical writing

Highly organized

Independent and proactive

Analytical mindset

AI savviness

Ausbildung

Ph.D. in Pharmaceutical Sciences / Biotechnology / Bioengineering or related life sciences

Equivalent relevant professional experience

Tools

MS Office

Jobbeschreibung

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 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.

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.