2025 Regulatory Affairs Operations Intern

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Job description

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Regulatory Affairs Operations Internship Overview

The Operations Submission Management Intern will support the regulatory operations team by helping to facilitate regulatory activities.

The intern will:

• Act as a member of the regulatory operations team by helping facilitate regulatory activities
• Be assigned to work in project management, regulatory submissions, or business operations
• Participate in business and/or technology initiatives
• Help streamline processes and offer suggestions for improvement

Key Responsibilities May Include:

• Managing 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.
• Participating in and facilitating team meetings, including expediting, managing, and coordinating team meetings.
• Assist Regulatory Operations colleagues by planning for and running 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.
• Actas 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.
• Executing Regulatory Lifecycle Management by maintaining Systems data standards, Regulatory lifecycle management, and providing User support, training, and metrics
• Contributing to Regulatory Business Management activities by developing and delivering Training, Communications and Change Management Strategy and Global Submission Support
• 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.

Qualifications

MinimumQualifications

• Currently enrolled in university, pursuing aBachelors degree inLife Science, Organizational Management, Business Technology, or other related field
• Expected graduation date between December 2025 June 2026
• Must be proactive and self-directed in a flexible in a fast-paced, timeline-driven and regulated environment
• Basic knowledge of Microsoft Office tools

Preferred Qualifications

• Project Management experience

Additional Information

Benefits and Amenities

• Competitive pay
• Relocation support for eligible students
• Select wellness benefits and paid holiday / sick time

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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