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
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico operations, focusing on regulatory affairs and compliance for biotechnological and orphan drug products. The role involves managing product registrations, lifecycle maintenance, and local health authority engagements in a hybrid work environment
Job Summary
The role focuses on managing local regulatory requirements and Health Authority engagements for biological and biotechnological products in Mexico and LATAM.
Responsibilities include new product registration, variations, renewals, import licenses, batch release, and 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 combining onsite and remote options.
Matching Summary
Match Score: 85
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico operations, focusing on regulatory affairs and compliance for biotechnological and orphan drug products. The role involves managing product registrations, lifecycle maintenance, and local health authority engagements in a hybrid work environment.
Skills & Requirements
Must-have
Local regulatory requirements expertise
Product registration and lifecycle management
Spanish and English fluency required
Health authority engagement experience
Biological and biotechnological product knowledge
Nice-to-have
Experience with orphan drug products
Familiarity with Veeva and TrackWise systems
Project management in global environment
Cross-functional team collaboration skills
Key Requirements
Bachelor's or Master's degree in life-sciences
5+ years of professional experience in local regulatory affairs
Expertise in DIGIPRIS and VUCEM health authority systems