Technical Regulatory CMC Writer – Belgium (Biologics/Pharma)

Alsinova; Waterloo; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Career progression

Challenging projects

Tailored career path

Continuous learning

Inclusive environment

Résumé du poste

Alsinova is seeking a Technical Regulatory CMC Writer based in Belgium to join our consulting team for pharma and biotech clients. You will handle technical writing for facilities and equipment across global regulatory files, coordinating with SMEs and QA teams to ensure timely submissions.

Requires 3+ years in CMC writing, knowledge of regulatory guidelines, and strong English/French communication skills. This role emphasizes cross-functional collaboration, data integrity, and rigorous review

Qualifications

• University level (Life Sciences background preferred) or equivalent by experience.
• At least 3 years of experience in writing CMC (technical) parts of regulatory documents.
• Experience working in validation/QA/production in Biologics/Pharmaceuticals industry.
• Knowledge of regulatory procedures / systems / guidance.
• Knowledge of biologic process and process equipment.
• Knowledge of Qualification / Validation principles.
• Manages own time to meet agreed short-term targets.
• Microsoft Office, PowerPoint & Excel proficiency.

Responsabilités

• Write CMC, “facility and equipment” parts and new files for WW regulatory File.
• Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.
• Ensure the coordination with the departments involved in the writing/review process.
• Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities.
• Monitor that supportive data provided by other departments are compliant.
• Report significant issues.
• Manage the projects within all company/GRA tracking tools.
• Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.

Connaissances

Good communication skills

Writing skills

Analytical thinking

Team player

Microsoft Office

PowerPoint

Excel

Formation

Life Sciences degree

Outils

Microsoft Office

PowerPoint

Excel

Description du poste

Alsinova is seeking a Technical Regulatory CMC Writer based in Belgium to join our consulting team for pharma and biotech clients. You will handle technical writing for facilities and equipment across global regulatory files, coordinating with SMEs and QA teams to ensure timely submissions.

Requires 3+ years in CMC writing, knowledge of regulatory guidelines, and strong English/French communication skills. This role emphasizes cross-functional collaboration, data integrity, and rigorous review