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. Demonstrates ability to apply clinical understanding and disease state knowledge in a regulated environment. Identifies and communicates routine Health Authorities filing needs. Functions within and has the responsibility for products or multiple indications for a product. Responsible (with manager’s oversight as needed) for educating internal customers on Regulatory issues including commercial, public affairs, clinical development, legal and others who contribute to regulated communication or communications that could be regulated. Maintains thorough knowledge of product data and key product issues. 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. Completes tasks and disseminates pertinent information to appropriate inter-departmental areas. Provides regulatory direction regarding marketed products and products in development to support the development of compliant and competitive promotional programs Serves as department representative on cross-functional projects. Responsible for supporting the department, division and company’s strategic direction and goals Understands and applies regulatory standards, guidances, promotional guidelines, and regulations With management guidance participates in the problem solving process by monitoring issues and implementing strategies for resolution. Analyzes and interprets information, impacting regulatory decisions Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems Prepares routine submissions in compliance with department and regulatory requirements and guidelines. Assists with larger or more complex submissions. Qualifications Required Education: High School diploma or certification, and 4 years industry related experience Preferred Education: Bachelor’s degree in (pharmacy, biology, chemistry, medical technology, pharmacology,) related life sciences Required Experience: 2-3 years in regulatory affairs, R&D or related area Experience working in a complex and matrix environment. Good communication, both oral and written Preferred Experience: Experience implementing successful regulatory strategies. Experience interfacing with government agencies Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) 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.