Regional Regulatory Lead - APAC, LATAM, MEA, CIS, Adriatics and Partner Business
Core
Portfolio-level regulatory strategist shaping regional approval pathways, life cycle management, and health authority relationships for a defined product portfolio across diverse markets.
Role type
Senior regulatory strategist (pharma/biotech)
Builds
Regional regulatory strategies and submission documentation for influenza vaccines and related products
Domain
Pharmaceutical regulatory affairs (global strategy implementation)
Required skills
Regional regulatory strategy development, health authority engagement, submission oversight, cross-functional collaboration, risk assessment, international legislation knowledge
Preferred skills
Additional languages (Arabic, French, Spanish, Russian), rare disease/orphan drug experience, toll manufacturing knowledge
Technologies
Marketing applications, life cycle management, PSURs
Responsibilities
Develop regional regulatory strategies aligned to global priorities, contribute to global regulatory strategy activities, provide strategic oversight of submissions, ensure high-quality submission documentation, build relationships with health authorities and internal stakeholders, stay current on international legislation
Seniority
Senior, hands-on IC