Regulatory Strategy Manager
Core
Develop and implement regional or global regulatory strategy for Vertex's development programs and marketed products, serving as a regional or global regulatory lead.
Role type
Senior IC regulatory strategy manager
Builds
Regulatory applications and submissions for drug development and registration
Domain
Biotechnology / Pharmaceutical regulatory affairs
Required skills
Global and regional regulatory affairs frameworks, drug development lifecycle, clinical trial design, statistics, clinical pharmacology, regulatory submission preparation, health authority interaction, strategic regulatory input, compliance assessment, regulatory intelligence analysis
Preferred skills
Problem-solving, complex scientific information assessment, competitive intelligence analysis, written and verbal communication, project planning and prioritization
Technologies
Regulatory submission systems, health authority portals
Responsibilities
Lead development and implementation of regulatory strategy for assigned region, contribute to global regulatory strategy, manage regulatory communications with local health authorities, provide guidance on regulatory requirements and approval pathways, manage preparation and submission of regulatory applications, provide strategic input for product development documents, ensure compliance of submissions, evaluate regulatory intelligence
Seniority
Senior, hands-on IC