Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines

Job description

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 productive relationship with HA contacts and driving positive regulatory outcomes for assigned product/s in conjunction with Global Regulatory Lead (GRL). Aspirational and future development opportunity to lead product health authority interact...