Senior Regulatory Specialist

Senior Regulatory Specialist Apply now Ready to make an impact across Europe? We're expanding our team and looking for a Senior Regulatory Affairs Specialist with solid experience in National Authorisation Procedures (NAT) and European regulatory affairs. This is an opportunity to work across Belgium, France, the Netherlands, Norway, Sweden, Ireland, Finland, and Switzerland , take ownership of high-impact regulatory activities, and help shape the future of our Regulatory Affairs organization. Join a team where learning by doing, collaboration, and initiative are truly valued. Your main responsibilities include: Manage parallel trade license applications and lifecycle activities across multiple European markets Own complex regulatory submissions, ensuring compliance with national and EU regulatory requirements Review and approve packaging materials, artwork files, regulatory documentation, and manage deviations Drive continuous improvement initiatives, including SOP development, process optimization, and regulatory excellence projects Act as a subject matter expert, partnering with stakeholders and supporting knowledge sharing across the organization What We're Looking For: At least 8 years of experience in Regulatory Affairs within the pharmaceutical industry, with strong knowledge of National Authorisation Procedures (NAT) and European regulatory requirements A proactive, hands-on professional who enjoys taking ownership and independently managing complex regulatory activities across multiple markets Strong communication and stakeholder management skills, with the ability to collaborate effectively across functions and build trusted partnerships A detail-oriented and quality-focused mindset, comfortable navigating changing priorities, deviations, and evolving regulatory landscapes A degree in Pharmacy, Life Sciences, Health Sciences, or a related field, combined with a passion for continuous learning, knowledge sharing, and process improvement 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. 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