Regulatory Start-Up PM - Lead Global Submissions (London)

Fortrea

Thatcham

Hybrid

GBP 80,000 - 120,000

Full time

3 days ago
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Benefits offered by this job

Hybrid work model

Job summary

Fortrea in London seeks a regulatory-focused Study Start-Up Project Manager to lead country-level submissions, approvals and site readiness for a global client-dedicated program.

You will oversee end-to-end regulatory submissions, IRB/IEC interactions, and local documentation, while coordinating with cross-functional teams to meet timelines and budget. This hybrid role offers ownership and visibility in a high-impact area.

Qualifications

  • 5+ years in clinical research with study start-up/regulatory exposure.
  • Strong knowledge of local regulatory environments and approvals.
  • Ability to manage multiple protocols and mitigate regulatory risk.
  • Excellent stakeholder management and influencing skills.

Responsibilities

  • Lead country-level regulatory submissions and approvals.
  • Oversee site readiness, vendors, and country processes.
  • Coordinate with CRM, CTC, CRA, Finance, and Legal on submissions and budgets.
  • Mentor and share best practices across regions.

Skills

Regulatory experience
Stakeholder management
Independence
Risk mitigation
IRB/IEC interactions

Education

Bachelor’s degree in Life Sciences

Job description

Fortrea in London seeks a regulatory-focused Study Start-Up Project Manager to lead country-level submissions, approvals and site readiness for a global client-dedicated program.

You will oversee end-to-end regulatory submissions, IRB/IEC interactions, and local documentation, while coordinating with cross-functional teams to meet timelines and budget. This hybrid role offers ownership and visibility in a high-impact area.

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