Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business
CSL Behring
Mexico City, Mexico
Hybrid
Local regulatory requirements expertise
Product registration and lifecycle management
Spanish and english fluency required
The role focuses on managing local regulatory requirements and Health Authority engagements for biological and biotechnological products in Mexico and LATAM
Job Summary
The role focuses on managing local regulatory requirements and Health Authority engagements for biological and biotechnological products in Mexico and LATAM.
Candidates will be responsible for new product registrations, variations, renewals, import licenses, and the evaluation of advertising materials to ensure compliance.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging.
Matching Summary
The role focuses on managing local regulatory requirements and Health Authority engagements for biological and biotechnological products in Mexico and LATAM.
Skills & Requirements
Must-have
Local regulatory requirements expertise
Product registration and lifecycle management
Spanish and English fluency required
Experience with biological and orphan drugs
Knowledge of DIGIPRIS and VUCEM systems
Nice-to-have
Project management skills for cross-functional teams
Experience with Veeva or TrackWise systems
Familiarity with GMP inspection processes
Ability to work in a hybrid remote/on-site model
Key Requirements
Bachelor's, Master's, or equivalent degree in life-sciences
5+ years of professional experience in local regulatory affairs