Senior Analyst, Regulatory Affairs Information Management jobs in United States
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AbbVie · 1 day ago

Senior Analyst, Regulatory Affairs Information Management

AbbVie is dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Analyst, Regulatory Affairs Information Management is responsible for ensuring the accuracy of regulatory data in the Cosmos system and providing guidance for product submissions throughout their lifecycle.

BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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Comp. & Benefits
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H1B Sponsor Likelynote

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
Responsible (with manager’s oversight as needed) for educating 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
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
Executes business processes for activity type and product information management within Cosmos

Qualification

Regulatory AffairsR&D ExperienceElectronic SubmissionsData StandardsCommunication Skills

Required

Bachelor's degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences
4+ years in regulatory affairs, R&D or related area
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
Prior experience in a regulatory affairs strategy role preferred

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs

Company

AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)

Funding

Current Stage
Public Company
Total Funding
$15B
2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO

Leadership Team

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Robert Michael
Chairman of the Board and Chief Executive Officer
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Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
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Company data provided by crunchbase