Senior Associate Regulatory Affairs Submission Management - Hybrid

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

About the Role

The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. This individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendors, and fulfills Submission Management functions on Project Teams supporting Development, Marketing, and post-marketing regulatory authority applications. This role is recognized as highly knowledgeable in regulatory affairs submission management.

Responsibilities

• Manages medium to high impact submission projects to ensure timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as the Regulatory Affairs Submissions interface with project teams, providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
• Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within required timelines. Anticipates obstacles and develops solutions within the team.
• Coordinates submission publishing with offsite publishers and provides notification to ensure all required resources are available to meet submission timelines. Prepares content planners for publishing and works with vendors to resolve publishing issues. May perform in-house publishing tasks.
• May serve as a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
• Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances, including verification of content, bookmarks, hypertext links, and tables of content in moderately complex submissions. Facilitates team reviews.
• Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
• Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high-quality submissions.
• Contributes to the creation and implementation of internal process and standards documents relating to publishing and publishing deliverables.

Some supervision is required. The individual receives project assignments from their manager but has responsibility for managing their own projects with some oversight. They review project progress with their manager on a regular basis with direction provided. This role involves training and mentoring less experienced staff.

This position will work a hybrid work schedule: 3 days in office and 2 days remote, from AbbVie’s North Chicago, IL headquarters.

Requirements

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.

Qualifications

• Required Education: Bachelor’s degree. Note: Years of experience may compensate for lower education.
• Preferred Education: PMP and RAC certificates are a plus.
• Required Experience: Four years of pharmaceutical or industry-related experience with publishing-related software tools, e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
• Preferred Experience:
  • 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.
  • Proven leadership skills and presence.
• Note: Higher education may compensate for years of experience.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• Eligible to participate in short-term incentive programs.

This job may include participation in bonus, commission, or incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable.