Regulatory Affairs Director Respiratory & Vaccine Therapeutic Area, Epd (m/f/d)
AbbVie
Weesp, Netherlands
Regulatory strategy development
Emerging markets expertise
Cross-functional leadership
Provide Strategic leadership to EPD Global Regulatory teams in developing and executing Regulatory strategies aligned to the business plans of EPD across different products, therapies and geographies
Job Summary
Provide Strategic leadership to EPD Global Regulatory teams in developing and executing Regulatory strategies aligned to the business plans of EPD across different products, therapies and geographies.
Represent Global RA in the Strategic Need State Teams to proactively develop mid and long-term portfolio strategies, KPIs, and improve innovation speed to market.
Provide Strategic Regulatory guidance, leadership and expertise to Regional Heads of Regulatory across all emerging markets and collaborate with commercial of these regions to ensure alignment of RA strategies to business.
Matching Summary
Provide Strategic leadership to EPD Global Regulatory teams in developing and executing Regulatory strategies aligned to the business plans of EPD across different products, therapies and geographies.
Skills & Requirements
Must-have
Regulatory strategy development
Emerging markets expertise
Cross-functional leadership
Regulatory intelligence and policy
External engagement strategy
Nice-to-have
Foster positive agency relationships
Improve innovation speed
Build advocacy positions
Key Requirements
15+ years of experience in RA, QA, Clinical/Medical Affairs and/or Manufacturing
5+/- years of experience at Leadership level
Experience in the Respiratory / Vaccine Therapeutic Area
Strong understanding of regulatory requirements / pathways