Responsibilities - Acquire and maintain parallel trading licenses, including dossier preparation, submissions, and lifecycle management - Prepare and proofread packaging materials, artwork files, mock-ups, item lists, and regulatory documentation - Communicate with competent authorities and stakeholders across assigned markets - Participate in continuous improvement initiatives and optimization of processes and systems - Support onboarding and training of colleagues within the team - Evaluate regulatory legislation changes and contribute to operational implementation - Participate in projects as an operational SME within Regulatory Affairs - Support maintenance of SOPs, working instructions,



and guidelines Requirements - 5+ years of experience within Regulatory Affairs - A Master’s degree or PhD within Pharmacy, Health Sciences, Life Sciences, or similar - Alternatively 8+ years of relevant Regulatory Affairs experience - Strong understanding of EU regulatory requirements and procedures - Professional proficiency in English - Professional proficiency in either Spanish and Portuguese / Italian - Experience working with packaging materials and documentation in a regulated environment - A structured and detail-oriented approach combined with a proactive mindset - Experience working with Adobe Creative Cloud in a technical or regulated environment is an advantage

📌 Associate Specialist, Regulatory Affairs (Madrid)
🏢 Jobtailor
📍 Madrid