North Chicago, IL, 60064, USA
1 day ago
Associate Director, Regulatory Affairs Strategic Global Labeling & Operations
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Regulatory Affairs Strategic Global Labeling and Operations, provides leadership, employee management, strategy and program management for Regulatory Affairs in the area of labeling using our current systems. Provides leadership in the optimization or development of new business processes, identifying business requirements and managing data migration into future systems. The Associate Director, leads cross-functional, multidisciplinary teams, and executes initiatives on projects having significant financial, legal or regulatory implications and manages staff and may manage a department. Responsibilities: + Serves as the subject matter expert (SME) relating to label management for Regulatory Affairs to develop strategies, processes and reporting tools and communicates these to management. + Comprehends the overall dependencies and impacts between label management and other types of submissions to build the most effective program for management of our data and documents. + Interacts with all areas of Regulatory Affairs, affiliates and other departments within the greater pharmaceutical organization. + Sets business product direction with vendors to assure that AbbVie’s requirements are met in future releases and enhancements. + Contributes to the development, coordination and execution of business processes with other regulatory departments, affiliates and other divisions. + Interacts with IT, business and management across Regulatory Affairs and with external companies to develop and update multi-year strategic plans related to label management. + Able to pull accurate metrics, queries and reports from regulatory systems and provide to Senior Management and/or to satisfy an audit request. + May have responsibilities for direct report employees or oversight of contract personnel. May indirectly manage the work of other department members. + Monitors the global regulatory environment for issues that impact area of responsibility and establishes impact to AbbVie. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required Qualifications + Required Education: Bachelor's degree. Preferred Education: Advanced degree - Regulatory Affairs Certification. + Required Experience: 8 years pharmaceutical or industry related experience. Keen awareness to cultural nuances; proven ability to work in a global environment. Strong attention to detail and problem solving skills. Ability to successfully interact and/or lead multi-divisional and multi-functional teams from across the globe. Ability to interact with senior management and executives. Effective use of negotiation skills to resolve issues. + Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA, Research & Development, Scientific Affairs, Operations or related area. Experience in international Regulatory Affairs. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​ + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ + This job is eligible to participate in our short-term incentive programs. ​ + This job is eligible to participate in our long-term incentive programs​ ​Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Salary: $133,500 - $253,500
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