Responsibilities

The Senior Director Global Regulatory Lead will develop and implement innovative global regulatory strategies for oncology products, serving as the accountable decision-maker for the development and execution of these strategies. They will lead the Global Regulatory Team, creating and maintaining a highly effective team, and be responsible for the creation and maintenance of the regulatory strategy, aligning local plans with global objectives. The GRL will represent regional regulatory plans to the global brand development team and at stakeholder meetings, ensuring alignment with business priorities and managing risks. Specifically, they will lead US and Canada submissions and agency interactions for preclinical and early clinical programs, while regional regulatory scientists will handle other agency interactions. The role involves providing solutions to development and regulatory barriers, and informing development plans through collaboration with the global brand development/program team.