Overview
Regulatory CMC Writer Position Belgium Jobs in Southwestern Ontario, Canada at Alsinova
Location: Southwestern Ontario
Join Alsinova as a Regulatory CMC Writer based in Belgium, focusing on technical documentation for pharmaceutical and biotech clients. Use your expertise to ensure regulatory compliance and project success.
In this consulting role, you will take on a range of responsibilities related to regulatory tasks, particularly in writing CMC sections and facility information for submissions. You will manage the complete writing and review processes, collaborating closely with SMEs to meet project deadlines. This position calls for at least three years of documented experience in regulatory writing for the pharmaceutical industry.
Key Responsibilities:
• Write and review CMC and facility regulatory submissions
• Schedule and manage writing processes with SMEs
• Support regulatory responses to authority inquiries
• Ensure compliance with data provided by other departments
• Utilize tracking tools for effective project management
Requirements:
• University degree or equivalent experience in Life Sciences
• At least 3 years’ experience in CMC writing
• Background in validation/QC within the pharmaceutical sector
• Proficient in Microsoft Office Suite;
French and English required
• Excellent writing, analytical, and communication abilities
Apply your CMC expertise to help drive successful regulatory outcomes for Alsinova’s diverse client base.
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Title: Regulatory CMC Writer Position Belgium
Company: Alsinova
Location: Southwestern Ontario, Canada
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