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Regulatory Affairs and Quality Technical Specialist

hace 2 meses

Madrid, Madrid, España Sin Nombre A tiempo completo

Job Summary

Sin Nombre is seeking a highly skilled Regulatory Affairs and Quality Technical Specialist to support the development and implementation of regulatory strategies for our products. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality.

Key Responsibilities

  • Collect and summarize regulatory intelligence to inform business decisions
  • Perform regulatory assessments to identify potential risks and opportunities
  • Participate in project teams to develop and implement regulatory strategies
  • Provide input for regulatory submissions and manage the compilation and review of all submissions for completeness and quality
  • Manage regulatory projects and collaborate closely with Clinical and Regulatory Operations teams
  • Provide tactical support for the timely preparation, editing, and review of submissions, including regulatory agency Meeting Requests and Briefing Documents
  • Coordinate and manage regulatory submission documents to produce submission-ready content
  • Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems
  • Assist with logging, tracking, and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding

Requirements

  • Strong understanding of regulatory requirements and industry standards
  • Excellent communication and project management skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
  • Strong attention to detail and ability to maintain high standards of quality