Advance your career with Alsinova as a CMC Regulatory Writer, serving clients in Belgium’s biotech and pharmaceutical sectors. Focus on technical writing to support critical regulatory submissions.
In this influential role, you will engage in writing technical documents for new and existing products, specifically focusing on CMC and facility aspects. Your responsibilities include coordinating with various departments, ensuring the timely execution of the writing process, and addressing queries from regulatory authorities. A background with a minimum of three years in industry-related CMC writing is essential.
Key Responsibilities:
• Draft comprehensive CMC and facilities documentation
• Manage the writing coordination with SMEs and departments
• Respond to regulatory inquiries effectively
• Verify compliance of department-provided data
• Maintain project management using GRA tracking tools
Requirements:
• University-level education in Life Sciences or similar...