Director, Regulatory Affairs & Quality Assurance - Mexico

The Role

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.

Here’s What You’ll Do

• Lead the development and execution of regulatory strategies for Moderna’s vaccine and biologics portfolio in Mexico, ensuring alignment with regional and global frameworks and successful delivery of submissions and lifecycle management activities across all programs.
• Serve as the primary regulatory representative with COFEPRIS, leading strategic authority engagement, including scientific advice, dossier discussions, and assessment of regulatory pathways (e.g., full review, reliance mechanisms, priority reviews and emergency authorizations).
• Oversee the preparation, submission and lifecycle manageme...