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. Role Overview: This position reports to the Oncology, General Medicine and Marketed Products Therapy Area Head, Regulatory Affairs - EEMEA Oversees the strategic input to assigned compounds/products in the context of the EEMEA geography Can be located in any country across EEMEA Key responsibilities: Define and implement Area & Affiliate regulatory strategies & deliverables for development compounds and marketed products in the Oncology for the EEMEA Ensure alignment with the overarching global regulatory strategy and in collaboration with the RA personnel in the affiliates Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) Develop a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates utilising the Area Regulatory Product Team (ARPT) meetings Primary RA interface with Commercial, and represent RA on the Brand Teams Provide leadership and support to regulatory affairs employees in the affiliates through ongoing communication and assisting in the development, training and mentoring of regulatory leaders Maintain an active awareness of EU and EEMEA legislation and assess its impact on AbbVie’s business and R&D programs jointly with Regulatory Intelligence Ensure regulatory compliance within EEMEA for assigned compounds/products and implement remediation plan to address identified gaps, if any Lead the Area initiatives, including the development of training programs for EEMEA affiliates, and be the lead in EEMEA for Global initiatives. Coach and mentor other more junior team members in the Area team. Transfer knowledge to the Area team Qualifications Pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Area and Regional team. European and EEMEA Area regulatory experience is essential Experience leveraging in-depth knowledge and understanding of products and the science behind them to develop commercialization strategy Strong communicator, able to engage across varied, international stakeholders Effectively problem-solving skills and capable to advocate on behalf of the local team with key influential skills Proven success in developing and maintaining constructive working relationship with government regulatory agencies, clinical, and commercial as applicable with HQ teams Travel Yes, 20 % of the Time Job Type Experienced Schedule Full-time Job Level Code M 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.