Regulatory Affairs Management
MMS regulatory affairs managers can act as a seamless extension of your regulatory affairs teams.
In addition to providing regulatory strategy consulting, these resources can be assigned as an actual product lead or a lead for a specific submission type.
Regulatory Affairs Management
MMS Regulatory Affairs Managers are an extension of Sponsor regulatory affairs teams. They are assigned to specific products and applications and work with Sponsor teams to execute regulatory activities and facilitate optimal progress/development.
Agency Representation and Regulatory Program Management
In addition to providing regulatory strategy consulting, these regulatory affairs managers are assigned as the actual product lead or lead for a specific submission type. Team members are responsible for
- communication of regulatory requirements and provision of status updates to stakeholders in the Sponsor company
- development of Module 1 content required for health authority interactions
- review of required regulatory documentation and files created by other functional lines
- representation to and interactions with the health authority(ies) on behalf of the Sponsor
Regulatory Affairs Submission Lead
Leads the team in the preparation and execution of large and/or complex dossiers
Module 1 as a Service
Regulatory Affairs Managers and Strategists can create regional, Module 1 documentation and provide the team with guidance on the content and format needed to support key interactions with global Health Authorities.
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