Associate, Regulatory Affairs Submission Management

Regulatory Jobs; Florham Park (NJ); Hybrid; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

AbbVie is seeking an Associate, Regulatory Affairs Submission Management to supervise low to medium impact submission projects and support cross-functional teams across development, marketing, and post-marketing regulatory activities. The role focuses on preparing content planners, coordinating publishing with vendors, and ensuring quality and compliance with regulatory guidance.

A Bachelor’s degree and two years of relevant experience are required, with preferred experience in publishing

Qualifikationen

• Bachelor’s degree required.
• Two years pharmaceutical or industry experience.
• Experience with publishing tools preferred.

Aufgaben

• Manages low to medium impact submission projects and ensures timely delivery of high quality dossiers.
• Provides guidance on submission processes and timelines to project teams.
• Coordinates submission publishing with offsite publishers and internal staff to meet deadlines.
• Performs detailed quality reviews of submitted content for compliance with regulatory standards.
• Contributes to process improvements within publishing and submission management.

Kenntnisse

Regulatory submissions

Regulatory affairs

Ausbildung

Bachelor’s degree

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Jobbeschreibung

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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The

Associate, Regulatory Affairs Submission Management

, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. The Associate establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications with input from the submission teams. The Associate is recognized as being knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities:

Manages low to medium 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 support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.

Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes 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

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 low to moderately complex submissions. Facilitates team reviews.

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 implementation of internal process and standards documents relating to publishing and publishing deliverables.

Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.

Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.

Position accountability/scope:

• o Supervision required
• o Receives project assignments from manager but has responsibility for managing own projects with oversight
• o Reviews project progress with manager on a regular basis with direction provided by manager
• o May assist with onboarding staff.

This position works a hybrid schedule (3 days in office) from the North Chicago, IL or Florham Park, NJ AbbVie 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

Required Experience: Two years pharmaceutical or industry related experience

Preferred experience: Publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.

NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education