Moderna is seeking a Director of Regulatory Affairs & Quality Assurance to lead its operations in Mexico City, focusing on developing regulatory strategies for mRNA vaccines and biologics. The role requires extensive experience in regulatory affairs within the pharmaceutical or biotech industry and offers opportunities for significant impact on public health
Job Summary
As Director of Regulatory Affairs & Quality Assurance, you will serve as the in-country leader shaping Moderna’s regulatory and quality strategy across Mexico.
You will operate at the intersection of science, compliance, and public health—ensuring timely access to innovative mRNA vaccines and biologics.
This role offers the opportunity to influence regulatory pathways, partner with health authorities, and embed advanced, digitally enabled quality systems.
Matching Summary
Match Score: 85
Moderna is seeking a Director of Regulatory Affairs & Quality Assurance to lead its operations in Mexico City, focusing on developing regulatory strategies for mRNA vaccines and biologics. The role requires extensive experience in regulatory affairs within the pharmaceutical or biotech industry and offers opportunities for significant impact on public health.
Skills & Requirements
Must-have
Regulatory strategy for biologics and vaccines
Interaction with COFEPRIS
CTD/eCTD submissions and lifecycle management
Quality Management System (QMS) oversight
Cross-functional collaboration
Nice-to-have
Next-generation regulatory tools
AI-enabled regulatory practices
Digital quality systems
Key Requirements
12+ years of experience in pharmaceutical/biotech industry
8+ years in regulatory affairs
Experience with cGMP requirements, QMS
Deep knowledge of Mexican regulatory frameworks
Eligibility to serve as Responsable Sanitario in Mexico