Senior Cmc Regulatory Technical Writer H/F - 78

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, whereAudacity, Care, and Energydefine 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
- 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