Project Management for Regulatory Affairs Professionals Training Course

Welcome, introductions and course objectives

• Introduction to course structure and learning outcomes
• Overview of what participants will achieve over the 2 days

Understanding regulatory projects: submissions, variations and lifecycle activities as strategic projects

• Define submissions, variations, renewals, and lifecycle activities as projects
• Understand regulatory projects as strategic initiatives

The Five P’s framework and project management methodologies (waterfall & agile in RA)

• Explore the Five P’s framework and lessons learned from RA delivery
• Overview of waterfall and agile methodologies in regulatory environments

Regulatory strategy and governance: aligning objectives with business and development strategy

• Align regulatory project objectives with business and development strategy
• Consider governance structures and decision-making in complex RA projects
• Overview of global regulatory pathways and submission strategies

Balancing the time–cost–quality–regulatory triangle & defining scope

• Define scope, objectives, and deliverables aligned with business strategy
• Balance the Time–Cost–Quality–Regulatory triangle

Developing the regulatory project plan (RPP) and target timeline plan (TTP)

• Learn to develop a Regulatory Project Plan (RPP)
• Create a Target Timeline Plan (TTP) to structure delivery

Work breakdown structures (WBS), RACI and Gantt Charts

• Use WBS, RACI matrices, and Gantt charts to plan and manage projects

Building regulatory-specific risk registers and contingency planning

• Identify and document regulatory-specific risks
• Develop contingency plans to mitigate risks

Communication planning and stakeholder alignment exercise

• Plan project communications for clarity and alignment
• Engage stakeholders effectively across regulatory projects

Stakeholder and cross-functional management in global RA projects

• Manage cross-functional and cross-cultural stakeholders
• Understand stakeholder dynamics in global regulatory projects

Gaining buy-in, managing expectations and regulatory operations as the coordination hub

• Gain project buy-in and manage stakeholder expectations
• Understand the role of Regulatory Operations as the project coordination hub

Monitoring, control and performance: dashboards, KPIs and escalation management

• Track submission readiness using dashboards and KPIs
• Apply reporting, meetings, and escalation processes to monitor performance

Time management and maintaining delivery momentum

• Plan and prioritise tasks effectively
• Maintain delivery momentum throughout the project lifecycle

Leadership and team performance: leading without authority, conflict management and team development

• Lead teams without direct authority
• Manage conflict and support team development
• Motivate and develop high-performing teams to achieve regulatory milestones

Project review and continuous improvement

• Conduct post-project reviews and capture lessons learned
• Embed continuous improvement into future regulatory projects

Future of RA project management: digital tools and artificial Intelligence – closing discussion & key takeaways

• Explore the future of regulatory project management
• Learn how digital tools and AI are shaping RA projects
• Key takeaways and closing discussion