Senior CMC Regulatory Technical Writer
Excelya · FR
Join Excelya as a Senior CMC Regulatory Technical Writer , where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold so...
Job description
About the Job Join Excelya as a Senior CMC Regulatory Technical Writer , where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements. This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding. Main Responsibilities: - 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 - Ensu...