Regulatory Submissions Lead — Hybrid Role

AbbVie; North Chicago (IL); Híbrido; USD 90.000 - 135.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO and holidays

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Descripción de la vacante

AbbVie seeks a Senior Associate, Regulatory Affairs Submission Management to drive medium-to-high impact submissions. You will coordinate cross-functional teams, establish content planners, and partner with publishing vendors to deliver high-quality dossiers on time.

The role supports development, marketing, and post-marketing regulatory authority applications, with a hybrid schedule across North Chicago, IL, or Florham Park, NJ. Bachelor’s degree required; PMP/RAC beneficial.

Formación

• Bachelor’s degree required; PMP/RAC beneficial.
• Regulatory submissions experience in pharma preferred.
• Experience with publishing tools and quality reviews.

Responsabilidades

• Manage medium to high impact regulatory submission projects.
• Interface with project teams and publishing vendors; guide timelines.
• Plan and conduct submission team meetings and ensure timely delivery.

Conocimientos

Regulatory affairs

Submission management

Project management

Cross-functional collaboration

Leadership

Educación

Bachelor’s degree

PMP certification

RAC certification

Herramientas

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Descripción del empleo

AbbVie seeks a Senior Associate, Regulatory Affairs Submission Management to drive medium-to-high impact submissions. You will coordinate cross-functional teams, establish content planners, and partner with publishing vendors to deliver high-quality dossiers on time.

The role supports development, marketing, and post-marketing regulatory authority applications, with a hybrid schedule across North Chicago, IL, or Florham Park, NJ. Bachelor’s degree required; PMP/RAC beneficial.