Manager, Regulatory Affairs Submission Management - Hybrid

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 Manager, Regulatory Affairs Submission Management, manages high-impact, complex submission projects involving multiple cross-functional regulatory submission teams. With input from the 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 in support of Development, Marketing, and post-marketing regulatory authority applications. The Manager is recognized as a discipline expert and resource in regulatory affairs submission management.

Responsibilities

• Independently manages high-impact submission projects (with respect to internal visibility, risk, complexity, and criticality) to ensure the 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 primary Regulatory Affairs Submissions interface with project teams, providing guidance and communication of established submission processes, standards, and technical specifications.
• Plans and negotiates submission project scope, 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 complex published submissions within the required timelines. Anticipates obstacles and develops solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks.
• May be 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.
• Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Facilitates team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances, including verification of content, bookmarks, hypertext links, and tables of content in complex submissions.
• Actively 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.
• Creates, implements, and finalizes internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions.
• May lead or participate on internal project teams to update business software.
• Trains, mentors, and may supervise the work of less experienced staff.

Position Accountability/Scope

• Minimal supervision required; receives project assignments from manager but has responsibility for managing own projects.
• Reviews project progress with manager on a regular basis with direction provided on follow-up.
• Provides estimates of activities with budgetary impact.

Qualifications

Required Education: Bachelor’s degree. Note: Years of experience may compensate for lower education.

Preferred Education: PMP and RAC certificates a plus.

Required Experience: 6 years’ pharmaceutical or industry-related experience with publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat). One to two years in cross-functional project management.

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 is preferred. Proven leadership skills and presence. Note: Higher education may compensate for years of experience.

Significant Work Activities

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

Benefits

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