Regulatory Affairs

Sanofi Genzyme

Bogotá, Colombia
Hybrid
3+ years leading regulatory teams
Experience with vaccines and biologics
Invima regulatory knowledge
The role involves leading local regulatory strategy as the country contact for registrations, post-approval changes, and portfolio rationalization specifically for biologics and vaccines

Job Summary

  • The role involves leading local regulatory strategy as the country contact for registrations, post-approval changes, and portfolio rationalization specifically for biologics and vaccines.
  • Sanofi is seeking a strategic partner to leverage advanced technologies like AI and bionic teams to accelerate drug delivery while maintaining the highest standards of quality and safety.
  • Candidates will manage cross-functional alliances and external stakeholders to drive integrated regulatory strategies and ensure compliance with local and corporate policies.

Matching Summary

The role involves leading local regulatory strategy as the country contact for registrations, post-approval changes, and portfolio rationalization specifically for biologics and vaccines.

Skills & Requirements

Must-have

  • 3+ years leading regulatory teams
  • Experience with vaccines and biologics
  • INVIMA regulatory knowledge
  • GxP compliance management
  • Spanish native and advanced English

Nice-to-have

  • Master's degree in Pharmacy
  • Knowledge of Central America and Peru regulations
  • AI and digital transformation experience
  • Strategic stakeholder influence
  • Competitive intelligence analysis

Key Requirements

  • University degree in Pharmacy
  • Minimum 3 years leadership experience
  • Deep expertise in vaccine regulatory affairs
  • Advanced English proficiency required

Work Rights

Not specified

Tailored Resume

Cover Letter