Course overveiw
Regulatory project management is no longer administrative - it is strategic. In an environment of global submissions, accelerated pathways, evolving health authority expectations and increasing cross-functional complexity, Regulatory Affairs professionals must deliver with precision, manage risk proactively and influence stakeholders - often without direct authority.
This two-day interactive course provides structured frameworks, practical tools and leadership capability to help Regulatory Affairs and Regulatory Operations professionals deliver submissions and lifecycle projects with greater clarity, confidence and control.
CPD Hours: 12
Course Content
- Day 1
- Welcome, introductions and course objectives
- Understanding regulatory projects: submissions, variations and lifecycle activities as strategic projects
- The Five P’s framework and project management methodologies (waterfall & agile in RA)
- Regulatory strategy and governance: aligning objectives with business and development strategy
- Balancing the time-cost-quality-regulatory triangle & defining scope
- Developing the regulatory project plan (RPP) and target timeline plan (TTP)
- Work breakdown structures (WBS), RACI and Gantt Charts
- Building regulatory-specific risk registers and contingency planning
- Communication planning and stakeholder alignment exercise
- Day 2
- Stakeholder and cross-functional management in global RA projects
- Gaining buy-in, managing expectations and regulatory operations as the coordination hub
- Monitoring, control and performance: dashboards, KPIs and escalation management
- Time management and maintaining delivery momentum
- Leadership and team performance: leading without authority, conflict management and team development
- Project review and continuous improvement
- Future of RA project management: digital tools and artificial Intelligence - closing discussion & key takeaways
Speakers
Laura Brown
Dr Laura Brown is an independent pharmaceutical project management and training consultant and Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. Laura has more than 25 years’ experience of managing projects in the pharmaceutical industry and has worked for several companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. Laura has completed an MBA, with specialisation in project management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management and the author of two books on the subject including the leading title, Project Management for the Pharmaceutical Industry.
