Senior Analyst, Regulatory Affairs, Labeling Operations
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. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Senior Analyst, Regulatory Affairs Registration and Label Management develops strategies, creates and maintains product registration and label information in source system(s). Responsible for reports, metrics, trending analysis and verification of registration and label management data.
- Creates, maintains and develops strategy for population of meta data and documents in our Registration and
- Label Management systems such as TRACTS (The Registration and Compliance Tracking System) and GLS (Global Labeling System).
- Develops queries, reports and metrics.
- Able to troubleshoot errors and system performance issues. Works with IT and/or vendor on business problem resolution and enhancements.
- Participates and contributes in group, department and cross-functional meetings. Interacts with all areas of regulatory affairs and affiliates to ensure registration and label management information is current, accurate and available in regulatory systems.
- Develops and executes business processes.
- May have responsibilities for direct report employees or oversight of contract personnel. May indirectly manage the work of other department members.
- Required Education: High School diploma or equivalent and 4 years of related experience
- Preferred Education: Bachelor’s Degree. Certifications a plus (RAC, PMP, Green/Black belt)
- Required Experience: 5 years pharmaceutical or industry related experience
- Experience working in a complex and matrix environment. Good communication skills, both oral and written
- Preferred Experience: Demonstrated analytical capabilities. Project management experience
- Proven leadership capabilities in a multi-disciplinary environment
- Experience/understanding/use of software tools
- Note: Higher education may compensate for years of experience. Years of experience may compensate for lower education.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
Job Level Code
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.