Specialist/Coordinator, Regulatory Affairs

Job Description

• Supports Regulatory Associate Director and team with the regulatory impact assessment, overall planning, validation of change scope and regulatory intelligence.
• Partners very closely with Country Regulatory Affairs and the Outsourcing Partner (for some processes) during the planning and execution of the business process or a project to collect necessary inputs for the accurate planning, validates country specific requirements.
• Participates in the country or sub-regional (project) meetings to ensure alignment between country and regional or global stakeholders.
• Acts as the global Artwork point of contact between the CRA’s and the Artwork Center to coordinate the AW implementation process (including regulatory management of the bundled changes and the shared packs)
• Forecasting of Artwork volume and planning
• Monitors the regulatory execution milestones (e.g HA submissions and approvals), facilitates the necessary follow-ups and escalations cross functionally and cross divisionally, as applicable.
• Prepares the metrics for the designated business process.
• Reports monthly and quarterly project updates by using the designated communication dashboards.
• Prepares high quality labeling, artwork packages, and conducts assessments of captioning and artwork management. These activities are aimed at supporting the timely submission of new Marketing Authorization Applications, variations, and supplementary marketing authorizations. These tasks are associated with labeling and artworks activities. Partnering with local CRAs to be able to submit to local authorities, maintains local files, updates tracking systems, databases, and handles minor translations.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

- Will be eligible to work for MSD in your country of residence

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Relocation:

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