Head of Regulatory Affairs / EMA

Head of Regulatory Affairs / EMA Apply now Drive meaningful change in the Head of Regulatory Affairs EMA In Regulatory, we obtain licenses for parallel trading of medicine. We do this by submitting applications to the European Medicines Agency and national medicine agencies of our sales countries. Our department is responsible for making sure that Abacus Medicine can parallel trade medicines as fast as possible while maintaining our obtained licenses. However, our biggest responsibility is to ensure patient safety all around the world! Your responsibilities as Head of Regulatory You will be responsible for overseeing multiple regulatory marketing authorization teams led by Deputy Managers. You will proactively lead the 6 Deputy Managers and oversee the Regulatory applications for new and existing product licenses for medicines to Authorities. You will lead optimization measures to be able to meet our KPIs and meet the needs of our commercial department. Your main responsibilities include: Accountable for performance KPIs across the area; Leading PI license applications and the maintenance thereof; Translate high-level strategies from senior leadership into cross-team action plans and support Regulatory to ensure quality and meet stakeholder expectations; Continuous development of the parallel distribution marketing authorization function; Provide strategic regulatory guidance and ensure alignment across all teams; Participate in the change management of increasing efficiency in licensing activities; Keep up to date with internal and external expectations; Take the responsibility of internal procedures and managing improvements; Oversee resource and capacity planning across multiple teams; Focus on employee satisfaction. Working in a rigidly regulated environment withing strict guidelines, following specific working instructions Skills that will make you succeed We are on the lookout for a dynamic leader with excessive experience in the pharmaceutical world, preferably with a pharmacist background. The ideal candidate will be an outstanding people manager, providing clear guidance and constructive feedback to his or her team. To drive success and foster a collaborative working environment, strong interpersonal skills and a flair for innovative thinking are essential. In addition, we expect that you: Have proven experience in a similar or relevant role; Have experience in structured administrative tasks; Masters degree in pharmaceutics, or life science, or regulatory affairs; Have 3+ years' experience in leader position, preferably in pharma/biotech and/or a pharma service organization; Minimum 3 years of experience in the Pharmaceutical or Healthcare industry, or Life Science background Preferable pharmacist background Fluent in English (written and verbal communication skills). Realize your opportunities with people who care The full team consists of 60 colleagues who are experts in the regulatory requirements need to do parallel trade in each of the markets we are currently selling. We coordinate daily with several internal and external stakeholders, to make sure that we are applying for the right licenses at the right time, receive them as fast as possible, and that we are will be producing products according to regulations. This requires us to be knowledgeable and to have good stakeholder management skills. On top of living up to our goals and requirements, we are an inclusive and friendly group of colleagues who are happy to help each other and share lunch together. What we offer: Support for work-life balance, flexible management approach; Abacus is a long-term opportunity, we encourage your professional development with internal job opportunities and trainings; Semi-annual company bonus; Cafeteria with optional elements; Annual salary increase; Employee referral program with high rewards; Private health insurance package provided by Medicare after 6 months of employment. AYCM SportPass membership opportunity; Interested? If you want to apply for the position, please follow the link and attach your CV. Would you like to know more about us? Follow us on Instagram and LinkedIn and get an insight into everyday life at Abacus Medicine. For job openings, check our Career page . Moving Healthcare. Moving You. In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine. But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,750 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move. Department Regulatory Locations Budapest - Kerepesi út 52 Remote status Hybrid Employment type Full-time