Regulatory Submissions Lead, RA Operations

AbbVie; United States; Hybrid; USD 110,000 - 165,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

401(k)

Job summary

AbbVie in the United States is seeking a Senior Associate, Regulatory Affairs Submission Management to lead medium to high impact submission projects with cross-functional teams. You will establish content planners, coordinate timelines, and liaise with publishers to ensure timely, compliant dossiers.

The role requires 4 years of pharmaceutical or industry experience with publishing tools and a proactive, collaborative style.

Qualifications

• Bachelor’s degree. Note: Years of experience may also compensate for lower education.
• PMP and RAC certificates a plus
• 4 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
• Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
• Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
• Proven leadership skills and presence
• NOTE: Higher education may compensate for years of experience.

Responsibilities

• Manages medium to high impact submission projects to ensure timely delivery of high-quality dossiers.
• Acts as RA Submissions interface with project teams and provides guidance on publishing timelines.
• Plans and conducts submission team meetings and coordinates multiple activities.
• Coordinates submission publishing with offsite publishers; prepares content planners for publishing.
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
• Facilitates creation of submission content deliverables such as cover letters and forms.
• Performs quality reviews of published output for regulatory compliance.

Skills

Regulatory submissions

Project management

Cross-functional teamwork

Leadership

Education

Bachelor's degree

PMP

RAC

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox

DocuBridge

Insight platform

Adobe Acrobat

Job description

AbbVie in the United States is seeking a Senior Associate, Regulatory Affairs Submission Management to lead medium to high impact submission projects with cross-functional teams. You will establish content planners, coordinate timelines, and liaise with publishers to ensure timely, compliant dossiers.

The role requires 4 years of pharmaceutical or industry experience with publishing tools and a proactive, collaborative style.