Regulatory Affairs Management

Our Regulatory Affairs Managers are responsible for supporting the following:

• Communication of regulatory requirements and provision of status updates to stakeholders in the Sponsor company
• Development of Module 1 content required for global health authority interactions, including the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and others
• Review of required regulatory documentation and files created by other functional lines
• Representation to and interactions with global health authorities on behalf of the Sponsor

Leads the team in the preparation and execution of large and/or complex dossiers

For more information on submissions support, see here.

Regulatory Affairs Managers and Strategists regularly create regional, Module 1 documentation and provide the Sponsor team with expert guidance on the content and format needed to support key interactions with global health authorities.