Associate Specialist, Regulatory Affairs (Madrid)

Associate Specialist, Regulatory Affairs (Madrid)

15 oct
|
ABACUS MEDICINE
|
Madrid

15 oct

ABACUS MEDICINE

Madrid

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 #J-18808-Ljbffr

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

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