Hybrid Regulatory Submissions Senior Associate

AbbVie; New Jersey; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie seeks a Senior Associate, Regulatory Affairs Submission Management to lead medium-to-high impact submission projects across cross-functional teams. You will establish content planners, coordinate publishing with vendors, and ensure compliance with regulatory standards, while working a hybrid schedule from AbbVie Florham Park, NJ or North Chicago, IL campuses.

Responsibilities include coordinating timelines, facilitating team meetings, reviewing submissions, and driving process

Qualifications

• Bachelor’s degree required; years of experience may compensate.
• 4 years’ pharmaceutical or industry-related experience with publishing related software tools.
• PMP and RAC certificates are a plus.

Responsibilities

• Manage medium to high impact submission projects to ensure timely delivery of high-quality dossiers that meet regulatory standards and are easily reviewed by agencies.
• Act as RA submissions interface with project teams, guiding submission processes and timelines.
• Plan and conduct submission team meetings; coordinate multiple activities for submission projects.
• Coordinate publishing with offsite publishers and resolve publishing issues; may perform in-house publishing tasks.
• Serve as a subject matter expert troubleshooting issues and providing technical systems support.
• Facilitate creation of submission content deliverables such as cover letters and forms.
• Perform detailed quality reviews to ensure compliance with Regulatory Standards and guidance.

Skills

Regulatory submissions management

Cross-functional collaboration

Project management

Regulatory knowledge

Education

Bachelor’s degree

PMP certification

RAC certification

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox

DocuBridge

Adobe Acrobat

Job description

AbbVie seeks a Senior Associate, Regulatory Affairs Submission Management to lead medium-to-high impact submission projects across cross-functional teams. You will establish content planners, coordinate publishing with vendors, and ensure compliance with regulatory standards, while working a hybrid schedule from AbbVie Florham Park, NJ or North Chicago, IL campuses.

Responsibilities include coordinating timelines, facilitating team meetings, reviewing submissions, and driving process