Regulatory Submissions Lead — Hybrid, High-Impact Role

AbbVie; Florham Park (NJ); Hybrid; USD 110,000 - 160,000; Full time

Job summary

AbbVie is seeking a Senior Associate in Regulatory Affairs Submission Management to lead mid-to-high impact submission projects and coordinate cross-functional teams. The role involves establishing content planners, facilitating team meetings, and interfacing with publishing vendors to ensure timely, compliant dossiers.

The ideal candidate has at least 4 years in pharma with publishing tools and strong leadership skills, plus familiarity with regulatory standards.

Qualifications

• Bachelor’s degree in a related field is required.
• Minimum 4 years of pharmaceutical or industry experience with publishing tools.
• Strong knowledge of regulatory submission processes and standards.
• Proven leadership skills and ability to influence without direct authority.
• Experience with publishing software and regulatory operations is preferred.

Responsibilities

• Manages medium to high impact submission projects ensuring timely delivery of high-quality dossiers.
• Acts as RA Submissions interface with project teams ensuring adherence to publishing timelines and standards.
• Plans and conducts submission team meetings and coordinates multi-product submissions.
• Coordinates submission publishing with offsite publishers and resolves publishing issues.
• Provides technical SME support and troubleshooting for submission-related systems.
• Contributes to process improvements and internal standards documentation.
• Maintains content planners and supports publishing operations across development, marketing and post-marketing work.

Skills

Team leadership

Regulatory submissions management

Cross-functional collaboration

Education

Bachelor’s degree

PMP and RAC certificates a plus

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie is seeking a Senior Associate in Regulatory Affairs Submission Management to lead mid-to-high impact submission projects and coordinate cross-functional teams. The role involves establishing content planners, facilitating team meetings, and interfacing with publishing vendors to ensure timely, compliant dossiers.

The ideal candidate has at least 4 years in pharma with publishing tools and strong leadership skills, plus familiarity with regulatory standards.