Regional Regulatory Affairs Manager

Work Your Magic with us!Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.Purpose of the rolePlan, oversee and monitor all operational Life Cycle Management activities for the countries and therapeutical areas under their responsibilities, ensuring adherence to Health Authority requirements and alignment with the company overall strategy while collaborating with the Regulatory Affairs Head and CRA team to achieve business objectives.Lead a team of Regulatory Coordinators, focusing on their development and performance, while implementing continuous improvement practices and data-driven analyses to enhance operational efficiency and service quality.Establish key performance indicators (KPIs), provide inputs for budget forecasts, and maintain effective communication with cross-functional stakeholders to address critical issues and drive successful regulatory initiatives.ResponsibilitiesEnsure effective planning, monitoring and support for all operational Life Cycle Management activities across designated countries and therapeutic areas, guiding the cluster team involved in projects. Maintain oversight of related regulatory activities until implementation. Facilitate the management, reporting and coordination for the countries and portfolios under their responsibilities and ensuring alignment with the company overall strategy. Ensure compliance with Health Authority requirements, functional SOPs, and other internal guidance and team operational agreements. Follow up of regulatory activities to guarantee that legal and internal deadlines are met and performance of all the post approval activities until implementation, in line with the deadlines. Align processes globally, regionally & locally, building cross-functional networks and using agile working methods. Identify and implement continuous improvement practices that increase output, reduce backlogs, and improve business processes, including addressing or even solving critical technical, operational and organizational challenges. Implement data-driven analyses to identify and develop improvements, and to improve data visualization in communications and reports to transmit clear information to senior leaders or other stakeholders. Lead the Uruguay HUB Regulatory coordinators; setting commitments, coaching, giving feedback, empowering and being responsible for the development, performance and results. Provide inputs for annual budget forecasts and then monitor and manage the budget across designated countries to ensure budget adherence in coordination with the country RA teams if applicable.Who You AreDegree in Pharmaceutical chemistry, Biochemical chemist or other Life Science degree.Exceptional verbal and written communication skills in English and Spanish; Portuguese proficiency is considered an asset.At least 4 years of experience in leading a high-performance team, with project management leadership experience an asset.Over 3 years of experience in regulatory affairs for Pharmaceutical Industry in Latin America, with expertise managing LCM regulatory variations and related activities for medicines portfolio.Knowledge of related mexican regulation is an asset.What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!