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Regulatory Affairs Specialist

1 semana atrás

Lisboa, Lisboa, Portugal TN Portugal Tempo inteiro
Job Description:

A Regulatory Affairs Associate will be responsible for ensuring compliance with applicable regulatory requirements, including EU guidelines and global frameworks. The role involves updating technical documentation, collaborating with cross-functional teams, and providing regulatory advice to project teams.

Responsibilities:
  • Update and maintain technical documentation in accordance with regulatory requirements.
  • Collaborate with R&D, Quality Assurance, and Clinical Affairs teams.
  • Ensure technical files are complete, current, and compliant with laws and standards.
  • Support quality & regulatory department in audits and inspections.
  • Provide regulatory guidance on product design, labeling, or manufacturing processes.
  • Monitor regulatory developments and advise on impact.


Requirements:

  • Minimum 1 year experience in Regulatory Affairs.
  • Knowledge of local and European pharmaceutical legislation.
  • Proficiency in English (B2 or higher) and knowledge of Spanish valued.
  • Bachelor or Master's degree in Life Sciences industry.