Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business
CSL Behring
Mexico
Hybrid
Local regulatory requirements
New product registration
Product lifecycle maintenance
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico office to oversee local regulatory affairs and health authority engagements for the LATAM region. The ideal candidate will have significant experience in regulatory affairs, particularly with biotechnological and orphan drugs, and will play a key role in product registration and lifecycle management
Job Summary
You will be responsible for new product registration, product lifecycle maintenance (variations, renewals), obtaining import licenses and local product batch release.
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations.
At CSL, Inclusion and Belonging is at the core of our mission and who we are.
Matching Summary
Match Score: 85
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico office to oversee local regulatory affairs and health authority engagements for the LATAM region. The ideal candidate will have significant experience in regulatory affairs, particularly with biotechnological and orphan drugs, and will play a key role in product registration and lifecycle management.
Skills & Requirements
Must-have
local regulatory requirements
new product registration
product lifecycle maintenance
Health Authority national engagements
biological and orphan drug products
Nice-to-have
innovative regulatory strategies
industry trends
global databases of regulatory submissions
inclusion and belonging
Key Requirements
Bachelor’s, Master’s, or equivalent degree in life-sciences
5+ years of professional experience in local regulatory affairs
Expertise in local health authority systems i.e., DIGIPRIS, VUCEM