The aims of this module are to enable students to consider and evaluate practical aspects of leadership and management required to run a successful regulatory affairs department responsible for the regulatory strategy of product development, maintena

1. Introduction 1.1 Definition of Regulatory Affairs 1.2 Importance of Management in Regulatory Affairs 1.3 Objectives of the Module 2. Leadership in Regulatory Affairs 2.1 Key Characteristics of Effective Leaders 2.2 Leadership Styles and Their Impact 2.3 Role of Leadership in Strategy Development 3. Management Skills in Regulatory Context 3.1 Project Management Techniques 3.2 Time Management in Product Development 3.3 Conflict Resolution Methods 3.4 Decision-making Processes 4. Regulatory Strategy Development 4.1 Components of a Regulatory Strategy 4.2 Strategic Planning for Compliance 4.3 Risk Management in Regulatory Affairs 4.4 Monitoring and Evaluation 5. Product Development Lifecycle 5.1 Phases of Product Development 5.2 Role of Regulatory Affairs in Each Phase 5.3 Integration of Regulatory Strategy 6. Maintaining Compliance 6.1 Understanding Regulatory Frameworks 6.2 Updating and Assessing Policies 6.3 Training and Development for Compliance 7. Challenges in Regulatory Affairs 7.1 Adapting to Changing Regulations 7.2 Managing Cross-functional Teams 7.3 Innovation vs. Regulatory Compliance 8. Future Trends in Regulatory Management 8.1 Digital Transformation in Regulatory Affairs 8.2 Impact of Globalization 8.3 Emerging Technologies and Regulations