enGene

Compliance

• Lead the day-to-day regulatory operations activities across assigned programs, ensuring timely, high-quality submissions to global regulatory agencies (FDA, EMA, etc.).
• Oversee preparation, formatting, publishing, and submission of documents for INDs, NDAs, BLAs, CTAs, MAAs, supplements, briefing documents, and more.
• Oversee the implementation of an Electronic Document Management System (EDMS).
• Manage the preparation, publishing, and archiving of submissions to global health authorities; guide internal teams on technical and regional requirements.
• Play a key strategic role in supporting the Global RA business by overseeing all regulatory submissions globally to ensure proper resourcing, planning and on-time execution from a project management and submission support perspective.
• Serve as subject matter expert on regional and technical submission requirements and regulatory document formatting.
• Collaborate cross-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance.
• Report directly to the Chief Regulatory Officer and lead best practices across regulatory systems and processes.

Director/Senior Director, Regulatory Affairs Operations