Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines
Core
Senior Manager leading regional regulatory strategy and execution for vaccines in North America, ensuring alignment with FDA and Health Canada requirements to achieve timely product approvals and market access.
Role type
Senior Manager, Regional Regulatory Lead
Builds
Regulatory filings, briefing documents, and strategic plans for influenza and other vaccines
Domain
Biopharmaceuticals / Vaccines / Regulatory Affairs
Deliverable
client delivery
Required skills
North America regulatory expertise, FDA and Health Canada interaction, regulatory filing pathway knowledge, risk assessment, stakeholder management, document preparation, competitive intelligence
Preferred skills
Advanced degree (MS, PhD, MD, DVM, MBA), matrix environment experience, leadership capabilities
Technologies
Regulatory systems
Responsibilities
Manage assigned product relationships with health authorities, provide guidance on regulatory requirements and filing pathways, lead or support core document preparation and product filing activities, contribute to global regulatory strategy and competitive intelligence, maintain relationships with internal GRAST members and external health authority contacts
Seniority
Senior Manager, hands-on leadership