Head Of Regulatory Submission Project Management

Ipsen

Multiple Locations
Hybrid
Regulatory submission project management
Global regulatory affairs collaboration
Risk and issue management
The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management organization overseeing both early-phase and late-phase regulatory submissions globally

Job Summary

  • The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management organization overseeing both early-phase and late-phase regulatory submissions globally.
  • This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle.
  • Ipsen builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact, empowering individuals to grow and thrive alongside the company’s success.

Matching Summary

The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management organization overseeing both early-phase and late-phase regulatory submissions globally.

Skills & Requirements

Must-have

  • Regulatory submission project management
  • Global regulatory affairs collaboration
  • Risk and issue management
  • Cross-functional stakeholder alignment
  • Regulatory project management governance
  • End-to-end submission delivery assurance

Nice-to-have

  • Human-centric leadership culture
  • Continuous process improvement
  • Matrix leadership and influence
  • Coaching and mentoring skills
  • Strategic scenario planning
  • Health Authority interaction readiness

Key Requirements

  • 10–15 years Regulatory Affairs/Pharmaceutical Project Management experience
  • Proven leadership of complex global regulatory submissions
  • Experience with IND, CTR, NDA, MAA, BLA submissions
  • Bachelor’s degree in scientific discipline
  • Fluent English

Work Rights

Not specified

Tailored Resume

Cover Letter