Manager, Regulatory Affairs Submission Management

Regulatory Jobs; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

AbbVie is seeking a Manager, Regulatory Affairs Submission Management to lead high-impact submission projects across Development, Marketing, and post-marketing programs. You will establish timelines, coordinate cross-functional teams, and interface with publishing vendors to deliver high-quality dossiers on time.

You will act as a subject-matter expert in submission management, guiding project scope, planning, and execution while ensuring compliance with regulatory standards and best practices

Qualifications

• Bachelor’s degree required; years of experience may compensate.
• 6 years’ pharmaceutical or industry experience with publishing software tools.
• Experience in project management within regulatory submissions.
• Knowledge of publishing standards and regulatory expectations.

Responsibilities

• Independently manages high impact submission projects to ensure timely delivery of high-quality dossiers meeting regulatory specifications.
• Acts as primary RA Submissions interface with project teams guiding submission processes, standards and timelines.
• Plans and negotiates submission scope, publishing timelines and deliverables with stakeholders.
• Plans and conducts submission team meetings and coordinates multiple activities to meet deadlines.
• Coordinates publishing with offsite publishers and vendors to resolve issues and ensure resources are available.
• Leads or participates on internal project teams to update business software and processes.

Skills

Team leadership

Cross-functional collaboration

Project management

Education

Bachelor's degree

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

About AbbVie

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. For more information about AbbVie, please visit us at

www.abbvie.com

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Manager, Regulatory Affairs Submission Management

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 vendor, 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 (with respect to internal visibility, risk, complexity and criticality)submission projects 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 RA 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 develop 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.

Position accountability/scope

• o Minimal supervision required


• o Receives project assignments from manager but has responsibility for managing own projects.


• o Reviews project progress with manager on a regular basis with direction provided on follow-up.


• o Provides estimates of activities with budgetary impact.


• o Trains, mentors and may supervise the work of less experienced staff.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Required Education

Bachelor’s degree.

Note: Years of experience may also 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 twoyears 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.