CMC Regulatory Technical Writer - Biotherapeutics

Ardena; Oost-Vlaanderen; Hybrid; EUR 60,000 - 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 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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

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

Education

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

Equivalent relevant professional experience

Tools

MS Office

Job description

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.