Specialist, Gra, Lrr Mexico, Region Latam & Partner Business
CSL Behring
Unknown
Hybrid
Local regulatory requirements expertise
Health authority management
Regulatory submissions management
This role involves developing and executing innovative regulatory strategies for new product registrations and lifecycle management activities while ensuring strict compliance with local regulations
Job Summary
This role involves developing and executing innovative regulatory strategies for new product registrations and lifecycle management activities while ensuring strict compliance with local regulations.
The Specialist acts as the primary interface with local Health Authorities and industry groups, representing the company's regulatory interests and leading in-country regulatory processes.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and fosters a culture of inclusion and belonging to drive innovation.
Matching Summary
This role involves developing and executing innovative regulatory strategies for new product registrations and lifecycle management activities while ensuring strict compliance with local regulations.
Skills & Requirements
Must-have
local regulatory requirements expertise
health authority management
regulatory submissions management
compliance with local regulations
project management skills
fluency in Spanish and English
hybrid work schedule
Nice-to-have
leadership skills
stakeholder engagement experience
experience in global matrix organizations
excellent organizational skills
ability to work independently and in teams
experience handling rapid change
expert MS Office skills
Key Requirements
3 to 5+ years regulatory experience
experience in regulatory authority facing role
fluency in Spanish and English oral and written
project and leadership experience managing regulatory submissions