Overview
Remote
30 - 33
Contract - W2
Contract - 12 Month(s)
No Travel Required
Unable to Provide Sponsorship
Skills
Submissions
Regulatory
Publishing
eCTD/NeES/Paper/IND
Job Details
• The Regulatory Publishing Associate is responsible for the planning, publishing (eCTD, NeES, paper), review and delivery of regulatory submissions to global Health Authorities within required timeframes. The primary accountability for this role is focused on the lifecycle submissions portfolio, but there is additional support for major/complex submissions. The Associate is responsible for the compilation, publishing, and technical quality control / troubleshooting of Regulatory submissions. The individual may also support the implementation of new systems and processes.
• Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSURs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.
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