Associate Specialist, Regulatory Affairs

Hace 3 días

Madrid, España Jobtailor Jornada completa

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