Module 10: Leadership and Strategic Management in Regulatory Affair

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Gives students an opportunity to evaluate the theoretical and practical aspects of leadership and management required to run a successful regulatory affairs department responsible for the regulatory strategy related to product development, maintenance and commercialisation.

Overview

It allows them to critically debate the management issues likely to arise in the running of a successful regulatory affairs department which is the key contact for main stakeholders in the organisation.

Students will increase their understanding of all the management and leadership skills needed to run a successful regulatory affairs department resulting in competitive advantage to the company and its main stakeholders.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Develop a systematic understanding and critical awareness of the practical management aspects of running a regulatory affairs department responsible for product development, maintenance and commercialisation
  • Demonstrate a critical knowledge of how to liaise and collaborate with other departments to ensure the appropriate documentation used in development, maintenance and commercialisation of healthcare products is in place
  • Possess a comprehensive understanding of the legal requirements and management theory governing regulatory strategies for product development, maintenance and commercialisation.

Skills and attributes

Successful students will typically:

  • Demonstrate the ability to understand the management and leadership skills required to run a regulatory affairs department as a manager, a leader or as a member of the team
  • Deal with complex issues both systematically and creatively, make sound management judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences, including working with other departments
  • Critically appraise and evaluate communications from regulations, guidelines, research and other publications regarding the management of a regulatory affairs department.

Focusing on leadership and management? Consider:

  • Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
  • Module 6: Regulatory Strategy: From Development to the Market Place
  • Module 7: Regulatory Strategy for Established Active Substances
  • Module 11: The US Regulatory Environment

Expanding your options? Consider:

  • Module 13: Principles of Medical Device Regulatory Affairs
  • Module 12: Data Management and Digitalisation in Regulatory Affairs
  • Module 18: Drug-device Combinations and Other Technologies