CMC Regulatory Expert Biopharma
At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.
This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.
Main responsibilities :
Define and lead the CMC regulatory strategy for complex projects, providing proactive guidance and expertise to cross-functional technical teams
Develop and maintain a global regulatory roadmap, ensuring alignment between manufacturing changes, regulatory requirements, and supply chain constraints
Oversee the preparation and submission of CMC dossiers, ensuring the robustness of comparability, validation, and quality data
Coordinate global regulatory submissions, optimizing timelines and ensuring compliance with regional requirements
Lead and manage interactions with Health Authorities, including addressing technical questions and supporting negotiations to facilitate approvals