Pharmaceutical Product Registrar

Há 4 dias


Lisboa, Lisboa, Portugal TN Portugal Tempo inteiro
Job Title: Regulatory Affairs Associate

Description:

We are looking for a highly motivated and experienced Regulatory Affairs Associate to join our team at TN Portugal. The successful candidate will be responsible for ensuring compliance with regulatory requirements, providing regulatory advice, and supporting the quality & regulatory department.

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.
  • Strong knowledge of local and European pharmaceutical legislation.
  • Excellent communication and problem-solving skills.
  • Bachelor or Master's degree in Life Sciences industry.


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