Regulatory Affairs Director

Denmark (DK)
Up to £120,000
28 Jan 2021
27 Feb 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level

The company

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.

The role

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.