Senior Associate, Regulatory Affairs Submission Management - Hybrid

AbbVie•Florham Park, NJ

5d•$84,500 - $162,000•Hybrid

About The Position

The 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 submission teams, this individual establishes and maintains submission content planners and timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendors, and performs Submission Management functions on project teams supporting Development, Marketing, and post-marketing regulatory authority applications. The role is recognized as highly knowledgeable in regulatory affairs submission management. The position receives project assignments from a manager and manages assigned projects with some oversight. The employee reviews progress with the manager regularly, with direction provided as needed, and trains and mentors less experienced staff. The work schedule is hybrid: three days in the office and two days remote, based at AbbVie’s Florham Park, New Jersey, or North Chicago, Illinois, headquarters. Continuous sitting for more than two consecutive hours in an eight-hour workday is required.

Requirements

Bachelor’s degree; years of experience may compensate for lower education.
At least 4 years of pharmaceutical or industry-related experience using publishing-related software tools.
Experience with publishing-related tools such as Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, or Adobe Acrobat.
Ability to manage assigned projects with some oversight and review progress regularly with a manager.
Continuous sitting for prolonged periods, defined as more than two consecutive hours in an eight-hour day.

Nice To Haves

PMP and RAC certificates are a plus.
Regulatory Affairs experience is preferred; experience in QA, R&D/support, Scientific Affairs, operations, or a related area may also be considered.
Regulatory Operations experience, including regulatory submission project management and/or submission publishing, is preferred.
Proven leadership skills and presence.
Higher education may compensate for years of experience.

Responsibilities

Manage medium- to high-impact submission projects to deliver high-quality dossiers on time and in compliance with regulatory authority technical specifications and navigation standards.
Serve as the Regulatory Affairs Submissions interface for project teams, communicating established submission processes and standards and contributing input to project scope, publishing timelines, and deliverables.
Plan and conduct submission team meetings; coordinate multiple concurrent, interrelated submission activities; anticipate obstacles and develop solutions with the team.
Coordinate submission publishing with offsite publishers, ensure resources are available, prepare content planners for publishing, and work with vendors to resolve issues; may perform in-house publishing tasks.
Troubleshoot technical issues and provide technical systems support as a subject matter expert, when needed.
Facilitate the creation or procurement of submission content deliverables, such as cover letters and forms.
Perform detailed quality reviews of published submissions for compliance with regulatory standards and health authority guidance, including verification of content, bookmarks, hyperlinks, and tables of contents; facilitate team reviews.
Suggest and contribute to process improvements, including software and business-process changes, and may participate on internal teams updating business software.
Build and maintain positive internal and external relationships; demonstrate leadership and influence without direct authority.
Contribute to developing optimal departmental business processes and standards to support customers and achieve high-quality submissions.
Contribute to creating and implementing internal process and standards documents related to publishing and publishing deliverables.
Train and mentor less experienced staff.