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. Primary Job Function: Support the execution of regulatory strategies for all products, assuring the inclusion of the latest regulatory framework, to get final approval of Marketing authorization at the best timeline possible and according with AbbVie policies. Ensure no significant business interruptions due to regulatory compliances issues. No market actions that impact patient safety. No critical observations from authority inspections /audits. Core Job Responsibilities: - Maintain product license in compliance with market supply, and local authority regulations. - Ensure alignment with all applicable SOPs. - Manage agency interface for safety and compliance issues. - Support local due diligence and Lex process, within the required timelines to ensure the compliance of planned launching dates. - Interactions with local regulatory authority as required, facilitating the review, responses to questions and approval of all local submissions in a timely manner. - Completion of any post approval commitments. - Provide Regulatory support for the timely submission of new drug applications. - Review and approval of promotional materials. - Lead all labeling harmonization / compliance processes, assuring KPIs results. - Ensure the maintenance of databases. - Provide regulatory support for cross functional programs and activities e.g. pricing, reimbursement Activity, government bids. - Ensure prescribing information, labels and other packaging components are in alignment with regulations and core safety information. Position Accountability/Scope: -Participation in Regulatory Intelligence, anticipating new regulation and competitors activities. -Coordinate and support the regulatory activities to align them with all business needs -No market actions that impact patient safety. -No significant business interruptions due to RA and QA compliance issues. Qualifications Requirements: -English advance level -At least 5 years of experience working within the pharmaceutical industry in quality and regulatory activities. -Good communication and negotiation skills. -Leadership Management skills. Travel No 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.