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

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