Regulatory Affairs Lead at Roche

The purpose of this role is to manage regulatory approval processes by understanding the requirements, monitoring and preparing submissions, engaging with key regulatory authorities and managing and driving approvals through the relevant processes as required.

You as the successful candidate will provide market relevant inputs into product design by understanding market requirements and regulatory frameworks, guiding design undertaken by Global, reviewing dossiers. development and providing feedback and recommendations to support regulatory approval across identified markets. You will manage implementation of Global regulatory strategies by identifying and developing regulatory approaches, encouraging engagement on proposed approaches and aligning for the respective market conditions as required and will manage maintenance of regulatory authorities by monitoring renewals, amendments and updates that are required an...