Regulatory Affairs Director for Global Distributor Management

3 weeks ago


Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full time

Job Summary

This is an exciting opportunity for an Associate Director to join the Gilead Global Regulatory Affiliates & Distributor team. The role requires effective stakeholder management and collaboration with cross-functional teams to oversee regulatory activities across the region.

Key Responsibilities

  • Management of regulatory capability for Gilead's in-market partners
  • Due diligence and distributor on-/off-boarding
  • Periodic regulatory training of in-market partners
  • Maintenance of legal agreements with in-market partners
  • Development of regional and national regulatory strategies
  • Partnership with the business to understand and support commercial and access needs
  • Proactive identification and resolution of emerging regulatory issues
  • Regulatory input to support product launch activities
  • Assessment and interpretation of regulatory intelligence

Requirements

  • Experience in regulatory affairs across international markets
  • Knowledge of regulatory requirements, including ICH requirements and regional requirements
  • Ability to lead cross-functional teams and develop regulatory strategy
  • Excellent verbal and written English communication skills
  • Excellent planning and organisational skills

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a leading biopharmaceutical company dedicated to delivering innovative therapies to patients worldwide. We are committed to advancing the science of medicine and improving the lives of people affected by serious diseases.



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