Job Description

Pay is commiserate with experience and ranges between $58-63/hr

Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.
Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools and applications.
Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.

Submissions support:
Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions.

Oversee outsourced publishing deliverables to ensure successful execution of operational activities for assigned products.

Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Responsible for electronic submissions and documents meeting regulatory agency and the companies submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
Competent in the use of electronic document management and submissions publishing tools.

Job Tags

Remote job, Contract work, Local area,

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