Associate Specialist, Regulatory Affairs (Madrid)

Associate Specialist, Regulatory Affairs (Madrid)

12 oct
|
ABACUS MEDICINE
|
Madrid

12 oct

ABACUS MEDICINE

Madrid

ResponsibilitiesAcquire and maintain parallel trading licenses, including dossier preparation, submissions, and lifecycle managementPrepare and proofread packaging materials, artwork files, mock-ups, item lists, and regulatory documentationCommunicate with competent authorities and stakeholders across assigned marketsParticipate in continuous improvement initiatives and optimization of processes and systemsSupport onboarding and training of colleagues within the teamEvaluate regulatory legislation changes and contribute to operational implementationParticipate in projects as an operational SME within Regulatory AffairsSupport maintenance of SOPs, working instructions, and guidelinesRequirements5+ years of experience within Regulatory AffairsA Master’s degree or PhD within Pharmacy,



Health Sciences, Life Sciences, or similarAlternatively 8+ years of relevant Regulatory Affairs experienceStrong understanding of EU regulatory requirements and proceduresProfessional proficiency in EnglishProfessional proficiency in either Spanish and Portuguese / ItalianExperience working with packaging materials and documentation in a regulated environmentA structured and detail-oriented approach combined with a proactive mindsetExperience working with Adobe Creative Cloud in a technical or regulated environment is an advantage#J-18808-Ljbffr

📌 Associate Specialist, Regulatory Affairs (Madrid)
🏢 ABACUS MEDICINE
📍 Madrid

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