Job description
Join Abacus Medicine and make medicines more accessible across Europe We are looking for an experienced Regulatory Affairs Specialist to join our Regulatory Affairs Pharma Trading team in Budapest. In this role, you will be responsible for managing regulatory activities related to parallel importation and trading licenses across multiple European markets, ensuring compliance with regulatory requirements while supporting business growth and operational excellence.
Your responsibilities
as a Regulatory Specialist Prepare, submit, and maintain parallel trading license applications and regulatory dossiers Create, review, and approve packaging materials, artwork files, mock-ups, and product documentation Ensure compliance with regulatory requirements across several European markets and monitor legislative changes Manage regulatory documentation, authority correspondence, and lifecycle activities Support cross-functional stakeholders, provide regulatory guidance, and contribute to process improvement initiatives Develop and maintain SOPs, work instructions, and best practices Train and mentor colleagues on regulatory processes and requirements.
Requirements
5+ years of Regulatory Affairs experience and a Master's degree/PhD in Pharmacy, Life Sciences, Health Sciences, or a related field; alternatively 10+ years of relevant Regulatory Affairs experience Strong understanding of EU pharmaceutical regulatory requirements and submission processes Experience preparing and reviewing regulatory documentation and packaging materials Fluent English, both written and spoken Strong stakeholder management, communication, and organizational skills 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 Sport. Pass 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.