Technical Regulatory Writer (CMC)

Ver: 190

Día de actualización: 26-11-2025

Ubicación: Wavre Walloon Brabant

Categoría: Marketing / PR Impresión / Publicación

Industria: Staffing Recruiting

Posición: Associate

Tipo de empleo: Full-time

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Contenido de trabajo

Write CMC, facility and equipment parts and new files for WW regulatory File
Manage and schedule 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 and report significant issues
Manage the projects within all GRA tracking tools
Assess the change controls that relate to pure facilities and equipment matters

Benefits

Challenging projects based on your interests and skills
Personal follow-up and clear, transparent communication both before and after commencement of employment
Possibility to follow extra training
Inspiring network events and legendary after work drinks
Strong network of industry leading clients
Expertise within IT, Engineering and Life Sciences
A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Have you got what it takes?

University level (Life Sciences background is preferred) or equivalent by experience
Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
Experience working in validation/QA/production in Biologics/Pharmaceuticals industry
Fluent English and French

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