2024 Regulatory Operations Submission Management Intern

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.com.

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Regulatory Operations Submission Management Internship Overview

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns.

The Operations Submission Management Intern will support the regulatory operations team by helping to facilitate regulatory activities. The focus will be to support project management, regulatory submissions, and business operations. 

Key responsibilities include:

·         Manage 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.

·         Participate in and facilitate team meetings, including expediting, managing, and coordinating team meetings.

·         Assist Regulatory Operations colleagues by planning for and running Global Regulatory Product Team (GRPT) meetings, managing the GRPT Plan, closely collaborating with Global Regulatory Leads (GRLs) and other GRPT members and/or partners across the enterprise, interacting with Area Regulatory Product Teams (ARPTs), and participating in calls with Health Authorities.

·         Act as Project Lead for a cross-functional initiative. This may include working with the project sponsor to identify objectives and approach for the initiative, developing the project charter, defining the project team, working with business SME and other project team members, and driving the activities and deliverables throughout the project life cycle.

·         Execute Regulatory Lifecycle Management by maintaining Systems data standards, Regulatory lifecycle management, and provide User support, training, and metrics.

·         Contribute to Regulatory Business Management activities by developing and delivering Training, Communications, and Change Management Strategy and Global Submission Support.

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

·         Suggest and contribute to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.

Minimum Qualifications 

·         Currently enrolled in university, pursuing a Bachelor’s degree in International Business, Life Science, Organizational Management, Business Technology, or other related field.

·         Must be enrolled in university for at least one semester following the internship.

·         Expected graduation date between December 2024 – July 2025.

·         Ability to be proactive, self-directed, and flexible in a fast-paced, timeline-driven, and regulated environment.

·         Ability to influence without direct authority. Builds and maintains positive relationships internally and externally.

·         Basic knowledge of Microsoft Office tools.

Benefits and Amenities

·         Competitive pay.

·         Relocation support for eligible students.

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.