Regulatory Submissions Lead, RA Ops & Publishing

Regulatory Jobs; Irvine (CA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

AbbVie is seeking a Senior Associate in Regulatory Affairs Submission Management. The role coordinates medium to high impact regulatory submissions, aligning cross-functional teams and vendors to deliver compliant dossiers on time.

You will guide publishing timelines, review content for regulatory standards, and contribute to process improvements within a global development portfolio. A Bachelor's degree and pharma submission experience are required, with PMP/RAC a plus.

Qualifications

• Bachelor’s degree required; PMP and RAC certificates are a plus.
• Experience with publishing-related software tools in pharma regulatory work.
• Experience leading regulatory submission activities and cross-functional teams.

Responsibilities

• Manages medium to high impact submission projects and timelines.
• Acts as RA submissions interface with project teams and publishing timelines.
• Plans submission team meetings and coordinates publishing with vendors.
• Performs quality reviews of published outputs for regulatory compliance.
• Supports process improvements and internal publishing standards.

Skills

Regulatory submissions management

Pharmaceutical industry experience

Publishing software tools

Education

Bachelor's degree

PMP certificate

RAC certificate

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie is seeking a Senior Associate in Regulatory Affairs Submission Management. The role coordinates medium to high impact regulatory submissions, aligning cross-functional teams and vendors to deliver compliant dossiers on time.

You will guide publishing timelines, review content for regulatory standards, and contribute to process improvements within a global development portfolio. A Bachelor's degree and pharma submission experience are required, with PMP/RAC a plus.