CRED 8 Presentations

01/07/2024

Organising your company

The Organisation for Professionals in Regulatory Affairs

33

Further info to come in theory vs reality

Organising your Company

• No one size fits all approach – depends on size of Company and functional organisation • Carefully map out submission contents (submission plan) and timelines • Start authoring early; this can be the best way to understand “gaps” • Hold dedicated meetings for specific modules and documents to drive to completion • Keep up team engagement, momentum; manage expectations • Hold regular “kick offs” and “check ins” • Don’t assume your team understand every step of the procedure • You are the expert to guide the team through regulatory expectations, guidance and scenarios • Resource planning is key; make sure the right people are available when needed • Be kind to your team, you need them! • Celebrate success along the way

The Organisation for Professionals in Regulatory Affairs

34