Module 1 2021

25/06/2021

RA needs to interact with all functions

Partner(s)/ CMO(s)

RA

Consultant(s)

RA

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The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

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RA professionals’ important roles

 Know the (global) regulatory environment  Ensure compliance with current regulations/ legislations at every stage of product development  Support expedite development by working within the regulations (consider future changes)  Advise & support: put ideas into practice and products on the market  Recommend and advise on regulatory requirements & strategies  Work/ communicate with Regulatory Authorities  Ensure successful regulatory strategy to meet the patients’ and companies/ business needs  Provide strategic, tactical and operational direction

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The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

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