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Regulatory Project Services

ICON is a full-service regulatory partner with industry-leading expertise in all areas of regulatory project management. 

We provide regulatory project management and submission management services with demonstrated success, facilitating delivery of timely and compliant dossiers worldwide. The ICON Regulatory Project Manager plays a pivotal role in managing budgets, submission forecasts, contracts and financial submissions. They work alongside the project team, coordinating and managing global regulatory project deliverables, including submissions, to obtain approvals in support of client goals. The Regulatory Project Manager will recommend simplified processes and supporting tools and technologies to provide seamless execution, project management and end-to-end regulatory submission delivery.

Key services

 

Strategic project management consulting:

  • Provide strategic guidance and operational execution across service lines
  • Ensure alignment with organisational goals and long-term vision

Cross-functional portfolio leadership:

  • Lead and manage cross-functional regulatory affairs initiatives
  • Service harmonisations
  • Acquisitions
  • Divestments
  • Global expansion
  • Drive collaboration among diverse teams to achieve project success

Submission management excellence:

  • Plan and execute submission timelines
  • Master timeline management
  • Monitor operational coordination
  • Track submission status
  • Report risks and issues
  • Ensure seamless coordination across functions

Financial management expertise:

  • Oversee project expenses
  • Budget tracking
  • Forecasting
  • Invoice reconciliation
  • Contract amendments
  • Optimise resource allocation and cost efficiency
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