Regulatory Specialist

Regulatory Specialist Apply now Your knowledge can open doors for patients worldwide — become a key driver of regulatory excellence with us. Come and join us as a Regulatory Specialist. The opportunity You’ll be joining a 6‑member Regulatory Marketing Authorization team that supports the British markets within a wider organization of approximately 130 colleagues. Our group plays a key role in both national (member‑state) marketing authorization processes and broader European regulatory activities. We would like you to: According to the requirements of the assigned end market, you will be responsible for: Acting as a specialist within the team Acquiring marketing authorizations for medicines in line with SOPs, WIs, and relevant regulatory guidelines Maintaining existing marketing authorizations according to market specific requirements and internal procedures Preparing and sending notifications to Trademark Holders in compliance with SOPs and WIs Managing end to end submission processes, ensuring high quality documentation and smooth cross functional collaboration Monitoring and interpreting regulatory and legislative changes, implementing them in daily operations Performing core operational regulatory tasks, including submissions, maintenance activities, compliance support, and documentation management Developing and maintaining SOPs, working instructions, and regulatory guidelines, and delivering internal trainings Participating in and occasionally leading ad hoc projects, such as proof reading or process improvement initiatives Providing professional guidance to junior colleagues and contributing to strategic decision making within the regulatory function. What we need you to have: 5+ years of regulatory expertise in a multinational environment Master’s/Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent field Strong ability to track, interpret, and apply legislative and regulatory changes Professional conduct in English (C1 level) Experience in communication with authorities and confidence in handling market specific regulatory expectations Ability to work independently, make well founded decisions, and contribute to strategic thinking within the regulatory function Capability to manage the full submission lifecycle: from business request to complete documentation, collaborating with graphic designers and business development Willingness to participate in operational tasks, including submissions, maintenance, compliance, SOP and WI creation, trainings, and ad hoc projects (e.g., proof reading) 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; Quarterly company bonus; Cafeteria with optional elements; Annual salary increase; Employee referral program with high rewards; AYCM SportPass membership opportunity; Private health insurance package provided by Medicare after 6 months of employment. Are you interested? If you want to apply, please use the apply link and attach your resumé. We look forward to receiving your application! 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 1,300 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