AbbVie

Senior Analyst, Regulatory Affairs, Labeling Operations

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Sep 13, 2020
Ref
2005876
Required Education
High School or equivalent
Position Type
Full time
About AbbVie
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, Labeling Operations 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.

Key Responsibilities:
  • Develops strategy for population of products/countries for the registration Management area
  • Develops queries creating compliance reports, metrics, trending analysis, verification of data
  • Responsible for monitoring area of responsibility for changing regulatory requirements that would impact the system
  • Works with IT and/or vendor on business problem resolution and enhancements
  • Interacts with all areas of regulatory affairs and affiliates
  • Develops and executes business processes for Registration Management
  • Executes business processes for Registration Compliance

Qualifications
  • 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)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.