Senior Associate, Regulatory Affairs Submission Management

Regulatory Jobs; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie, a global biopharmaceutical company, is seeking a Senior Associate in Regulatory Affairs Submission Management. The role coordinates cross-functional teams to deliver regulatory submissions, maintains content planners, and interfaces with publishing vendors to ensure timely, compliant dossiers for development, marketing, and post-marketing programs.

This position emphasizes leadership, mastery of publishing tools, and strong communication with project teams.

Qualifications

• Bachelor’s degree required.
• Four years’ pharmaceutical or industry experience with publishing tools.
• Experience with publishing software such as Documentum and ISI Publisher is preferred.

Responsibilities

• Manages medium to high impact submission projects to ensure timely delivery of high-quality dossiers.
• Acts as RA Submissions interface with project teams providing guidance on submission processes and standards.
• Plans and conducts submission team meetings and coordinates multiple activities to meet publication timelines.

Skills

Leadership

Regulatory submissions

Project coordination

Cross-functional collaboration

Education

Bachelor’s degree

PMP

RAC

Tools

Documentum

ISIPublisher/eCTDXPress

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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Senior Associate, Regulatory Affairs Submission Management

, manages medium to high impact, moderately 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. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities:

Manages medium to 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 RA 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 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.

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.

Position accountability/scope:

Some supervision required

Receives project assignments from manager but has responsibility for managing own projects with some oversight

Reviews project progress with manager on a regular basis with direction provided by manager

Trains, and mentors less experienced staff.

This position will work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie North Chicago, IL headquarters.

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:

Four years’ 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 is preferred.

Proven leadership skills and presence

NOTE: Higher education may compensate for years of experience.