Regulatory Specialist

Hely: Budapest
Cég: ABACUS MEDICINE HUNGARY Kft.
Kategória: Egészségügy, Gyógyszeripar

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 opportunityYou’ll be joining a 10‑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 teamAcquiring marketing authorizations for medicines in line with SOPs, WIs, and relevant regulatory guidelinesMaintaining existing marketing authorizations according to market specific requirements and internal proceduresPreparing and sending notifications to Trademark Holders in compliance with SOPs and WIsManaging end to end submission processes, ensuring high quality documentation and smooth cross functional collaborationMonitoring and interpreting regulatory and legislative changes, implementing them in daily operationsPerforming core operational regulatory tasks, including submissions, maintenance activities, compliance support, and documentation managementDeveloping and maintaining SOPs, working instructions, and regulatory guidelines, and delivering internal trainingsParticipating in and occasionally leading ad hoc projects, such as proof reading or process improvement initiativesProviding professional guidance to junior colleagues and contributing to strategic decision making within the regulatory function. 5+ years of regulatory expertise in a multinational environmentMaster’s/Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent fieldStrong ability to track, interpret, and apply legislative and regulatory changesProfessional conduct in English (C1 level)Experience in communication with authorities and confidence in handling market specific regulatory expectationsAbility to work independently, make well founded decisions, and contribute to strategic thinking within the regulatory functionCapability to manage the full submission lifecycle: from business request to complete documentation, collaborating with graphic designers and business developmentWillingness to participate in operational tasks, including submissions, maintenance, compliance, SOP and WI creation, trainings, and ad hoc projects (e.g., proof reading) 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.

Címkék: Employee status, University

profession.hu - kb. 7 órája

További információ és jelentkezés