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AMISEQ · 1 week ago

Regulatory Affairs Specialist

United States

Contract

Remote

New Grad, Entry Level

AMISEQ is a company specializing in regulatory affairs, and they are seeking a Regulatory Publishing Associate. This role involves planning, publishing, and delivering regulatory submissions to global Health Authorities, ensuring technical quality control and supporting the implementation of new systems.

AnalyticsCyber SecurityInformation TechnologyProfessional Services

Growth Opportunities

Hiring Manager

Shiva Prasad Karu

Responsibilities

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

Qualification

Regulatory submissionsECTD publishingVeeva PublishingTechnical quality controlTroubleshooting

Required

Responsible for the planning, publishing (eCTD, NeES, paper), review and delivery of regulatory submissions to global Health Authorities within required timeframes

Primary accountability for this role is focused on the lifecycle submissions portfolio

Additional support for major/complex submissions

Responsible for the compilation, publishing, and technical quality control / troubleshooting of Regulatory submissions

Support the implementation of new systems and processes