Job Description
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 management of regulatory dossiers in CTD/eCTD format, including marketing authorizations, CMC variations, renewals, labeling updates, safety updates, post‑approval commitments, and responses to regulatory queries.
- Ensure compliance with all applicable Mexican regulatory requirements for biologics and vaccines, including oversight of GMP ...