Lead regulatory initiatives at Seqirus Vaccines as the Senior Manager, Regional Regulatory Lead focused on North America. Engage with FDA and Health Canada to drive successful product outcomes.
This position is pivotal in the Global Regulatory Strategy team at Seqirus Vaccines, ensuring regulatory alignment with the Global Regulatory Affairs Strategy Team. You will leverage your extensive North American regulatory experience to maintain vital relationships with health authorities. Contribute to and lead critical regulatory deliverables while applying your expertise to achieve positive regulatory outcomes.
Key Responsibilities:
• Manage health authority relationships with FDA and Health Canada
• Provide regulatory guidance and risk assessments to stakeholders
• Support core document preparation and product filing activities
• Contribute to strategy development and competitive regulatory intelligence
• Foster relationships across Global Regulatory Strategy
Require...