Presented by
Management Forum
Project Management for Regulatory Affairs Professionals In-house Training
Delivering regulatory projects in complex global environments.
Designed for regulatory professionals stepping into senior project leadership roles or responsible for complex, global and high-visibility submissions.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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.
This training course is part of our collection of Leadership & Management Training Courses which focus on leadership, innovation, strategy, communication, finance, problem solving and conflict management, to name a few key areas.
Benefits of attending
By the end of the course, participants will be able to:
- Apply structured project management methodologies to regulatory submission and lifecycle activities
- Build realistic regulatory project plans, risk registers and communication strategies
- Lead cross-functional stakeholders effectively to deliver milestones on time and compliantly
Who should attend
This course is designed for professionals working in Regulatory Affairs and Regulatory Operations across pharmaceuticals, biotechnology and medical devices, including:
- Regulatory affairs associates, specialists and managers
- Regulatory project managers, coordinators and submissions leads
- Regulatory operations professionals supporting global submissions
It is suitable for both newer professionals seeking structure in managing regulatory projects
and experienced managers aiming to strengthen cross-functional leadership and delivery
impact.
This course will cover:
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
Laura Brown
Independent Pharmaceutical Consultant
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.
United Kingdom
- SincasPharma Ltd
