Regulatory Affairs Director
- Experience Level
My client are clinical stage biotech developing immune therapies for the treatment of cancer. Their pipeline of first-in-class anti-cancer therapies is based on a unique platform technology enabling the activation of T cells that are specific for immune inhibitory molecules. They have just received £110 million of Series B funding to advance their pipeline which has a range of compounds Pre-Clin to Phase 3.
Responsible for developing innovative global regulatory strategies and working with the cross-functional project team on execution.
Serve as the primary interface for FDA/EMA on assigned projects and prepare the team for meetings with FDA/EMA and other Regulatory Agencies.
Lead and coordinate: CTAs/INDs/MAAs/BLAs/Breakthrough Designation/PRIME
Educates company on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
Represent Regulatory Affairs in several internal cross-functional teams, like the project core-team, Clinical Teams and Study Teams, etc. Present and defend regulatory plans to the senior management and project review boards.