The Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as:
Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.
Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) members to ensure appropriate inputs into risk assessment and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA.
Engaging with local health authority (HA), FDA and Health Canada, maintaining p...