Director, Regulatory Affairs & Quality Assurance - Mexico

Moderna Inc

Mexico City, Mexico
Not specified; benefits include fitness, mindfulne...
70% in-office, 30% remote
Regulatory strategy for biologics and vaccines
Cofepris interaction and dossier management
Responsable sanitario legal eligibility
Moderna Inc is seeking a Director of Regulatory Affairs & Quality Assurance in Mexico City to lead the regulatory strategy and quality assurance for its mRNA products. The ideal candidate will have extensive experience in regulatory affairs, particularly with vaccines and biologics, and will be responsible for ensuring compliance with local regulatory frameworks

Job Summary

  • This role serves as the in-country leader shaping Moderna's regulatory and quality strategy across Mexico to ensure timely access to innovative mRNA medicines.
  • The successful candidate will act as the legally appointed Responsable Sanitario, leading strategic engagement with COFEPRIS and managing complex regulatory pathways including reliance mechanisms and emergency authorizations.
  • Moderna offers a holistic approach to well-being with benefits including family building support, generous paid time off, and a culture that values in-person collaboration through a 70/30 work model.

Matching Summary

Match Score: 85

Moderna Inc is seeking a Director of Regulatory Affairs & Quality Assurance in Mexico City to lead the regulatory strategy and quality assurance for its mRNA products. The ideal candidate will have extensive experience in regulatory affairs, particularly with vaccines and biologics, and will be responsible for ensuring compliance with local regulatory frameworks.

Salary

Not specified; Benefits include fitness, mindfulness, mental health support, family building benefits, and generous paid time off

Skills & Requirements

Must-have

  • Regulatory strategy for biologics and vaccines
  • COFEPRIS interaction and dossier management
  • Responsable Sanitario legal eligibility
  • CTD/eCTD submission lifecycle management
  • GMP compliance and QMS oversight
  • Cross-functional leadership in matrixed environment

Nice-to-have

  • Experience with AI-enabled regulatory practices
  • Fluency in English and Spanish
  • Strategic influence on health policy
  • Background in digital transformation of quality systems

Key Requirements

  • 12+ years pharmaceutical/biotech experience
  • 8+ years in regulatory affairs
  • Eligibility to serve as Responsable Sanitario
  • Advanced degree (PharmD, MSc, PhD) preferred
  • Deep knowledge of Mexican regulatory frameworks

Work Rights

Must be eligible to serve as Responsable Sanitario in Mexico

Tailored Resume

Cover Letter