Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business
Century Center
Mexico City, Mexico
Hybrid
5+ years local regulatory affairs experience
Fluency in spanish and english required
Expertise in digipris and vucem systems
This role focuses on managing local regulatory requirements and Health Authority engagements for biological, biotechnological, and orphan drug products in Mexico and LATAM
Job Summary
This role focuses on managing local regulatory requirements and Health Authority engagements for biological, biotechnological, and orphan drug products in Mexico and LATAM.
The position involves overseeing new product registrations, lifecycle maintenance, 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 hybrid work schedule that combines onsite and remote work.
Matching Summary
This role focuses on managing local regulatory requirements and Health Authority engagements for biological, biotechnological, and orphan drug products in Mexico and LATAM.
Skills & Requirements
Must-have
5+ years local regulatory affairs experience
Fluency in Spanish and English required
Expertise in DIGIPRIS and VUCEM systems
Bachelor's or Master's in life sciences
Experience with biological and orphan drugs
Nice-to-have
Experience with Veeva, TrackWise, GLAMS systems
Project management skills for cross-functional teams
Knowledge of GMP inspection processes
Ability to work effectively in a hybrid environment
Key Requirements
Bachelor's, Master's, or equivalent degree in life-sciences
5+ years professional experience in local regulatory affairs
Required fluency in Spanish and English oral and written
Expert knowledge of Mexican health authority systems (DIGIPRIS, VUCEM)