Senior Regulatory Submissions Specialist - Hybrid & Publishing

AbbVie Inc.; Florham Park (NJ); Híbrido; USD 85.000 - 162.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Healthcare + 401(k)

Descripción de la vacante

AbbVie Inc. is seeking a Senior Associate, Regulatory Affairs Submission Management for a hybrid role in Florham Park, NJ (3 days in office, 2 days remote) with options at North Chicago, IL.

The position involves managing medium to high impact regulatory submission projects and coordinating cross-functional teams to ensure timely, compliant dossiers. The role requires pharmaceutical industry experience and familiarity with publishing tools; salary ranges from 84,500 to 162,000 USD annually, with

Formación

• 4 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.

Responsabilidades

• Manages medium to high impact submission projects to ensure the timely delivery of high-quality dossiers that meet regulatory specifications and are easily navigated by agencies.
• Acts as RA Submissions interface with project teams, providing guidance on submission processes and publishing timelines.
• Plans and conducts submission team meetings, coordinates activities for submissions and products, and anticipates obstacles with solutions.
• Coordinates submission publishing with offsite publishers, prepares content planners, and resolves publishing issues; may perform in-house publishing tasks.
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.

Descripción del empleo

AbbVie Inc. is seeking a Senior Associate, Regulatory Affairs Submission Management for a hybrid role in Florham Park, NJ (3 days in office, 2 days remote) with options at North Chicago, IL.

The position involves managing medium to high impact regulatory submission projects and coordinating cross-functional teams to ensure timely, compliant dossiers. The role requires pharmaceutical industry experience and familiarity with publishing tools; salary ranges from 84,500 to 162,000 USD annually, with