Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business
CSL Limited
Mexico
Hybrid
Local regulatory requirements
New product registration
Product lifecycle maintenance
CSL Limited is seeking a Local Regulatory Responsible (LRR) for its Mexico sales affiliate, focusing on regulatory requirements and health authority engagements for new product registration and lifecycle management. The ideal candidate should have over five years of regulatory affairs experience, particularly with biological and biotechnological products, and be fluent in both Spanish and English
Job Summary
Focus on local regulatory requirements and Health Authority national engagements for new product registration, product lifecycle maintenance, import licenses, and local product batch release.
Responsible for the evaluation of advertising materials, primarily for biological, biotechnological, and orphan drug products.
This is a hybrid role, offering a combination of an onsite and remote work schedule.
Matching Summary
Match Score: 85
CSL Limited is seeking a Local Regulatory Responsible (LRR) for its Mexico sales affiliate, focusing on regulatory requirements and health authority engagements for new product registration and lifecycle management. The ideal candidate should have over five years of regulatory affairs experience, particularly with biological and biotechnological products, and be fluent in both Spanish and English.
Skills & Requirements
Must-have
local regulatory requirements
new product registration
product lifecycle maintenance
import licenses
local product batch release
evaluation of advertising materials
biological, biotechnological, and orphan drug products
Nice-to-have
innovative regulatory strategies
industry trends
global environment
cross-functional teams
Key Requirements
5+ years of professional experience in local regulatory affairs
Bachelor’s, Master’s, or equivalent degree in life-sciences
Expertise in local health authority systems i.e., DIGIPRIS, VUCEM