Senior Associate, Regulatory Affairs Submission Management - Hybrid
AbbVie
AbbVie seeks a Senior Associate in Regulatory Affairs Submission Management to oversee medium to high-impact submission projects, coordinate cross-functional teams, and ensure timely delivery of high-quality regulatory dossiers. The role involves managing submission timelines, publishing coordination, quality assurance, and mentoring junior staff in a hybrid environment.
Responsibilities
- Manage medium to high-impact submission projects ensuring timely, compliant dossier delivery to regulatory authorities
- Establish and maintain submission content planners, timelines, and coordinate cross-functional regulatory teams
- Plan submission meetings, coordinate concurrent activities, and develop solutions to obstacles within project scope
- Coordinate publishing with external vendors, prepare content for publication, and perform detailed quality reviews
- Train and mentor less experienced staff; suggest process improvements and contribute to departmental standards
Requirements
- Bachelor's degree in any field
- 4+ years pharmaceutical or industry experience with publishing software (Documentum, eCTDXPress, ISIPublisher, Adobe Acrobat)
- Demonstrated leadership skills and organizational presence
- Experience in regulatory affairs, operations, QA, R&D, or scientific affairs preferred
- Project management experience, regulatory submission management, or submission publishing experience preferred
- PMP and RAC certifications a plus
Vacancy posted 5 days ago
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