Impactful CMC Regulatory Writer (Biologics/Pharma)

Alsinova; Belgique; Remote; EUR 60,000 - 90,000; Full time

Job summary

Alsinova is seeking a Technical Regulatory Writer (CMC) to join our regulatory team in Belgium. The role focuses on technical writing for facilities and equipment for global regulatory submissions, coordinating with SMEs and QA/production to ensure timely completion.

Ideal candidates have a Life Sciences background and at least 3 years of CMC writing experience in Biologics/pharmaceuticals, with strong English and French language skills, and the ability to work across departments on complex

Qualifications

• University level Life Sciences background preferred or equivalent by experience.
• At least 3 years of experience writing CMC (technical) parts of regulatory documents (registration files or variations).
• Experience in validation/QA/production in Biologics/pharmaceuticals industry.

Responsibilities

• Involved in regulatory activities related to new and existing products, domestically or internationally, focusing on technical writing for facilities, major and minor submissions.
• Write CMC, facility and equipment sections for WW regulatory files.
• Coordinate with SMEs and site conformance, production, validation and QA to manage the writing/review process for timely completion.
• Ensure coordination with departments involved in the writing/review process and respond to regulatory authority questions.

Skills

English fluency

French language

Communication skills

Written communication

Analytical skills

Team player

Education

Life Sciences degree

Tools

Microsoft Office

PowerPoint

Excel

Job description

Alsinova is seeking a Technical Regulatory Writer (CMC) to join our regulatory team in Belgium. The role focuses on technical writing for facilities and equipment for global regulatory submissions, coordinating with SMEs and QA/production to ensure timely completion.

Ideal candidates have a Life Sciences background and at least 3 years of CMC writing experience in Biologics/pharmaceuticals, with strong English and French language skills, and the ability to work across departments on complex