Senior Analyst - Regulatory Affairs Label Management

November 7

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AbbVie

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Biopharmaceutical • Biotechnology • Innovation • Research and Development • Manufacturing

10,000+

Description

• Responsible for monitoring labeling activity in Cosmos • Ensures completeness and accuracy of RIM data • Works with labeling and submission teams for managing product submissions • Determines system properties for classification and submission types • Elevates non-compliant records for resolution • Uses electronic-based applications for daily tasks • Educates internal customers on Regulatory information issues • Functions independently in decision making for routine issues • Reviews complex issues and problem resolutions

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, medical technology or pharmacology related life sciences • 4+ years in regulatory affairs or R&D • Experience in a complex global matrix environment • Good communication, both oral and written • Preferred: Experience with electronic regulatory submissions and data standards

Benefits

• Comprehensive package of benefits • Paid time off (vacation, holidays, sick) • Medical/dental/vision insurance • 401(k)