Regulatory Affairs Management
Leading regulatory affairs managers can act as a seamless extension of Sponsor regulatory teams.
Thanks to MMS and especially the team… we reset the relationship that we have with the FDA and moved our lead asset forward through to getting our clinical trial started.
MMS regulatory strategy experts provide consulting and can be assigned as the product lead or a lead for a specific submission type, if needed.
MMS Regulatory Affairs Managers are a true extension of Sponsor regulatory affairs teams. These knowledgeable, experienced resources are assigned to specific products and applications and work with Sponsor teams to execute regulatory activities and facilitate optimal progress and development.
Our Regulatory Affairs Managers are responsible to support 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 FDA, 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.
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