Project Management for Regulatory Affairs Professionals Training Course

Understanding project management in the regulatory context

• What defines a “project” in Regulatory Affairs? (submissions, renewals, MA variations, etc.)
• The Five P’s framework for managing submissions and lifecycle projects
• Overview of project management methodologies, including waterfall and agile
• Lessons learned from previous Regulatory Affairs projects

Regulatory project objectives and strategies

• Defining clear project goals, scope, and deliverables
• Balancing the Time-Cost-Quality-Regulatory Triangle
• Aligning project objectives with business and regulatory strategies
• Considering regulatory options and pathways

Project planning and scheduling for regulatory projects

• Developing a Regulatory Project Plan (RPP)
• Integrating the Target Timeline Plan (TTP) into project planning
• Conducting effective project kick-off meetings
• Using Work Breakdown Structures (WBS)
• Creating responsibility matrices (RACI) to clarify roles across RA and Operations teams
• Constructing Gantt charts to define deliverables, dependencies, and milestones
• Budget and resource considerations in regulatory projects
• Developing a communication plan
• Building a regulatory-specific risk register and developing contingency plans
• Using project management software and tracking systems

Work breakdown structures, RACI and Gantt Charts

Risk registers, contingency planning and communication planning

Project management tools and tracking systems

Cross-Functional and cross-cultural stakeholder management

• Effective communication and gaining project buy-in
• Managing stakeholder expectations (internal management, regulatory bodies, partners)
• Communicating effectively with project stakeholders across cultures
• Managing cross-functional communication between Regulatory, CMC, QA, Clinical, and regulatory agencies

Project execution and control

• Monitoring submission readiness and progress (tracking systems, dashboards, KPIs)
• Regulatory Operations as the hub of project coordination
• Key performance indicators (KPIs) for RA project performance
• Effective meetings, reporting, and escalation management

Leadership

• The evolving role of the Regulatory Project Manager / Lead
• Core regulatory leadership competencies
• Leadership styles and adaptability
• Leading without direct authority - motivating diverse teams to achieve common goals
• Motivation and performance in achieving regulatory milestones
• Stages of team development toward cross-functional performance
• Conflict-resolution styles and approaches

Time management, project review and closure

• Time-management processes for regulatory affairs projects
• Conducting a regulatory post-project review
• Documenting lessons learned and best practices
• Embedding continuous improvement into future projects

Future of RA project management: using artificial intelligence