Head Of Regulatory Affairs Brazil - São Paulo (sp)

Sandoz

São Paulo, Brazil
Product registration submission
Regulatory strategy implementation
Health authority interactions
The Head of Regulatory Affairs in Brazil directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports

Job Summary

  • The Head of Regulatory Affairs in Brazil directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.
  • Responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
  • Sandoz is the global leader in Biosimilar and Generic medicines, touching the lives of more than 1 billion people across 100+ countries.

Matching Summary

The Head of Regulatory Affairs in Brazil directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.

Skills & Requirements

Must-have

  • product registration submission
  • regulatory strategy implementation
  • Health Authority interactions
  • dossier submission and approval
  • risk management plans review

Nice-to-have

  • cross-cultural experience
  • functional breadth
  • agile and collegiate environment
  • diversity of thought welcomed

Key Requirements

  • Cross Cultural Experience
  • Functional Breadth
  • Project Management
  • Operations Management and Execution
  • Representing the organization
  • Clinical Trials
  • Cross-Functional Teams
  • Detail Oriented
  • Drug Development
  • Lifesciences
  • Negotiation Skills
  • Problem Solving Skills
  • Regulatory Compliance
  • Risk Management
  • English language proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter