MSD Specialist Regulatory Shared Service Delivery 

Argentina, Buenos Aires 

89387976

Job Description

The SSDM 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,

Specific responsibilities include:

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.

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 Contingent Workers apply

Language(s) Job Description:

Requirements:

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

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

07/08/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.