Location is flexible within the EEMEA region.
The SSDM ( Shared Services Delivery Model ) Regulatory Coordinator supports the SSDM Associate Director and will partner with the functional areas and Country Regulatory Affairs to ensure the regulatory post-approval operations in scope of SSDM (i.e. Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids, labeling activities and artwork implementation) are planned, managed, and executed timely and accurately, issues are identified and resolved, and opportunities for improvement of the business processes are pursued.
Specific Responsibilities Include
- 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 CRAs 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.
Education
- Bachelors or masters degree preferred or equivalent work experience in life science, engineering, business or a related field (ideally pharmaceutical science degree)
- Minimum 2-3 years experience in pharmaceutical industry
- Previous experience in Regulatory, CMC or Quality is preferred.
- Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
- Strong interpersonal skills and capacity to work across the geographies with the high number of stakeholders.
- Detail oriented
- Ability to communicate effectively, both verbally and written, with others across all levels of the organization
- Ability to work in a matrix organization.
- Competent user of Microsoft Office
- Technology proficient; Interest in new tools or automatization will be needed.
- Demonstrated ability to self-start and work independently on tasks given.
Current Contingent Workers apply HERE
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Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Shift
Valid Driving License
Hazardous Material(s)
Requisition ID R270675
