Lead regulatory strategies for vaccines at CSL Seqirus in Kirkland, Québec. This hybrid role seeks a seasoned manager with significant North America regulatory expertise.
CSL Seqirus is looking for a Senior Manager, Regional Regulatory Lead for North America to enhance regulatory outcomes for vaccine products. You will partner with Global Regulatory Affairs Strategy Team members, engage health authorities like the FDA and Health Canada, and guide risk assessments to ensure seamless product development. This position balances regulatory leadership with practical team collaboration to foster timely and successful outcomes.
Key Responsibilities:
• Lead health authority interactions, focusing on FDA and Health Canada
• Provide guidance on regulatory pathways and requirements
• Contribute to core document preparation and submission activities
• Coordinate GRAST strategies and ensure timely execution
• Maintain relationships with internal and external stakeholders
Req...