Management Support - Services Examples

woman placing sticky notes on wall
woman placing sticky notes on wall

  • Interim management support. Management of small (N~10 people) to large Team (N~120 people) of regulatory managers and experts whether located in one site or remotely located in different sites

  • Project management of development program, registration dossier and post-approval license maintenance activities, including interaction and support to Technical teams.

  • CMC issue management (e.g. supply issue, product deviation, recall). Analysis of issue and identification of the appropriate scientific and regulatory remediation strategy. Communication with Authorities, including authoring and review of Biological Product Deviation Report and Product Defect Form management. Management of internal and external regulatory stakeholders.

  • Risk management. Identification of risk and mitigation actions associated with regulatory processes and projects.

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