Senior CMC Regulatory Technical Writer

Join Excelya as a Senior CMC Regulatory Technical Writer, where you will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation.

Requirements

• Author, review, and finalize high-quality CMC sections (Module 2.3 and Module 3) for Phase 3 and Marketing Authorization Applications
• Prepare briefing documents and responses to Health Authority questions as required
• Collaborate with CMC technical teams (process development, formulation, analytical, manufacturing) to collect and interpret data
• Manage submission workflows within the electronic document management system (eCTD environment)
• Ensure consistency, accuracy, and scientific integrity of all regulatory narratives
• Manage timelines across multiple projects and proactively communicate risks
• Provide guidance and support to internal stakeholders when needed

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan