Senior Analyst, Regulatory Affairs Label Management (Remote)

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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

The Senior Analyst of Regulatory Affairs Label Management is responsible for monitoring the labeling activity in Cosmos (the Regulatory Information Management system) for products and ensuring the completeness and accuracy of RIM data in the Cosmos system. This role works with the Strategic Global Labeling and submission teams to provide appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in Cosmos, as described in functional area procedures, and for managing product drug listings.

Responsibilities:

• Determines system properties appropriate for the classification type/submission type of object desired by the business in Cosmos.
• Elevates non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations.
• Demonstrates ability to apply knowledge in a regulated environment.
• Demonstrates ability to use electronic-based applications and systems, such as DocX Tool, Label/Regulatory Intelligence platforms, eDMS, data analytics tool(s), etc., for completing daily tasks.
• Educates internal customers on Regulatory information issues including commercial, public affairs, clinical development, legal, quality, and others who contribute to RIM.
• Functions independently in decision making for routine issues and completes labeling inquiries from cross-functional areas, often under tight timelines.
• In conjunction with manager, reviews complex issues and problem resolution successes and setbacks to assist in future problem-solving applications/options.
• Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems.
• Prepares routine communications for functional area and senior leadership as requested, including core labeling information dissemination.
• Executes business processes for product information management within Cosmos, labeling document reviews (format and content) and for drug listings.

Qualifications

Qualifications:

• Required Education: Bachelors degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences.
• Required Experience: 4+ years in regulatory affairs or R&D.
• Experience working in a complex global matrix environment with diverse team members.
• Good communication, both oral and written.
• Preferred: Experience working with electronic regulatory submissions and data standards andprior experience in a regulatory affairs strategy role.

Open to remote anywhere in the United States. If you are located within 50 miles of an AbbVie office, a hybrid schedule may be required.

Additional Information

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.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

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.

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