Module 1 2021

25/06/2021

Strategy: managing within • Key: relationship and communication between HQ team and local team plus other suppliers – ONE TEAM • All players to know and understand roles • Start early • Regular updates • Handle on global situation • Integration with Clinical and Commercial throughout strategy- building and execution • Publicise the successes – look for replications elsewhere • Learn from “failures”

The Organisation for Professionals in Regulatory Affairs

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Four Pillars for Strategic + Operational Success

ALIGNMENT – Mutual understanding HQ  Region  Country  [agency] – Clarity on roles and responsibilities

– Senior management awareness, planning and reporting – Key stakeholders internally in manufacturing, labelling etc. – If using a 3rd party – ensure equivalent clarity PEOPLE – Hiring, training, coaching, retention. Differentiating roles: leader, strategist, writer, compiler, publisher, expert INTELLIGENCE – Capture, harness, interpret and exploit. Map the future and use that intelligence as influencing lever. PROCESSES – Routine where at all possible. Appropriate standard while achieving compliance. Simple limited KPIs/measures.

The Organisation for Professionals in Regulatory Affairs

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