Role Description:
Within this role you will act as EU Regulatory Lead and be responsible for one or more products, developing and executing regional regulatory strategies. You will plan and manage regulatory submissions for marketed and development products such as:
*Clinical trial applications and / or post approval variations
*Responses to agency questions in compliance with global filing plans and local regulatory requirements
*Provide regulatory direction on regional regulatory mechanisms to optimize product development
*Review and approve promotional and non-promotional materials for use in international region
*Should be a self-starter, able to work independently with some strategic direction from supervisor
Background Experience:
*In depth regulatory experience across marketed and development products
*Centralised experience dealing with the EMA
*Oncology experience preferred but not required