Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business

CSL Behring

Mexico City, Mexico
Hybrid
Local regulatory requirements expertise
Product registration and lifecycle management
Health authority engagement experience
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico City affiliate to manage local regulatory requirements, including product registrations and lifecycle maintenance for biotechnological and orphan drugs. The role is hybrid, blending onsite and remote work, and requires extensive experience in regulatory affairs

Job Summary

  • The role focuses on managing local regulatory requirements and Health Authority engagements for biological and biotechnological products in Mexico and LATAM.
  • Candidates will be responsible for new product registrations, variations, renewals, 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 combining onsite and remote options.

Matching Summary

Match Score: 85

CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico City affiliate to manage local regulatory requirements, including product registrations and lifecycle maintenance for biotechnological and orphan drugs. The role is hybrid, blending onsite and remote work, and requires extensive experience in regulatory affairs.

Skills & Requirements

Must-have

  • Local regulatory requirements expertise
  • Product registration and lifecycle management
  • Health authority engagement experience
  • Spanish and English fluency required
  • Biological and biotechnological products 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
  • Fluency in Spanish and English oral and written

Work Rights

Not specified

Tailored Resume

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