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