Associate Director, Global Regulatory Affairs Job at Ipsen, Cambridge, MA

  • Ipsen
  • Cambridge, MA

Job Description

Ipsen seeks an Associate Director of Global Regulatory Affairs to develop and execute regulatory strategies for assigned biopharmaceutical programs. This role bridges R&D, commercial operations, and regulatory functions, ensuring compliant implementation across development and marketed products while maintaining regulatory intelligence on emerging trends.

Responsibilities

  • Develop and adapt regulatory strategies for assigned portfolio programs across regions
  • Provide regulatory guidance on target product profiles, indications, and label optimization
  • Lead cross-functional teams to define and execute global regulatory plans with appropriate sequencing
  • Monitor competitive and scientific landscape for regulatory impact; communicate emerging trends
  • Conduct regulatory due diligence, manage outsourced activities, and lead operational excellence initiatives

Requirements

  • Extensive regulatory affairs experience in biopharmaceutical development
  • Demonstrated expertise in global regulatory strategy and health authority interactions
  • Strong cross-functional leadership and stakeholder management skills
  • Knowledge of target product profiling and commercialization regulatory considerations
  • Experience with regulatory intelligence and competitive analysis in therapeutics
  • Advanced degree in life sciences, pharmacy, or related field preferred

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