Regional Regulatory Lead
Core
Portfolio-level regulatory strategist defining regional pathways, lifecycle management, and health authority relationships for diverse markets (APAC, LATAM, MEA, CIS, Adriatics) to ensure global strategy execution.
Role type
Senior regulatory strategist (portfolio level)
Builds
Regional regulatory strategies, submission documentation, and health authority engagement plans
Domain
Pharmaceutical/Biotech regulatory affairs
Required skills
Regional regulatory strategy development, health authority engagement, submission lifecycle management, risk assessment, cross-functional collaboration, emerging market regulatory knowledge
Preferred skills
Additional languages (Arabic, French, Spanish, Russian), rare disease/orphan drug expertise, toll manufacturing knowledge
Technologies
Marketing applications, PSURs, reliance pathways
Responsibilities
Develop regional regulatory strategies aligned with global priorities; oversee submissions and lifecycle management; build relationships with health authorities and internal stakeholders; anticipate regulatory risks; ensure high-quality documentation delivery
Seniority
Senior, hands-on IC