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Expertly delivering clinical trials operations, with care.
Senior CMC Regulatory Technical Writer
Location
France
Posted
94 days ago
Salary
0
Seniority
Senior
Job Description
Senior CMC Regulatory Technical Writer
Excelya
• 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 • Ensure alignment of all documentation with global regulatory requirements (ICH, FDA, EMA) • Develop, maintain, and continuously improve CMC regulatory dossier templates in line with evolving guidelines • 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
Job Requirements
- Minimum 10 years of experience in CMC within the pharmaceutical industry and CMC regulatory technical writing
- Excellent writing, editing, and organizational skills
- Strong understanding of regulatory requirements and guidelines (ICH, FDA, EMA, etc.)
- Ability to work collaboratively in a fast-paced environment.
- Degree in Pharmacy or a relevant scientific field (Chemistry, Biology, or equivalent)
- Fluent in written and spoken English
Benefits
- At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience.
- Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects.
- Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
- Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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