Regulatory Affairs Associate

Há 2 dias

Lisboa, Lisboa, Portugal Kelly Tempo inteiro


Kelly Life Sciences is currently recruiting a Regulatory Affairs Officer to join our clients team, in Lisbon.

Job Description:
As a Regulatory Affairs officer, your responsibilities will include:

  • Update and maintain technical documentation for medicinal products in accordance with applicable regulatory requirements, including but not limited to the EU guidelines, and other global regulatory frameworks.
  • Collaborate with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather necessary documentation and data.
  • Ensure all technical files are complete, current, and in compliance with relevant laws and standards.
  • Support the quality & regulatory department (QARA), in audits and regulatory inspections.
  • Provide regulatory advice and guidance to project teams on regulatory requirements, especially related to changes in product design, labeling, or manufacturing processes.
  • Monitor regulatory developments within the medical device field and advise on impact and necessary actions.

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

      Please apply by sending your CV through our portal.

      A Kelly Services atua na qualidade de Agência de Emprego, em relação à presente oferta. Informamos que se optar por se candidatar, as suas informações serão tratadas de acordo com a Declaração de Privacidade da Kelly Services.
      _______

      Kelly Services acts as an Employment Agency in relation to this offer. Please be advised that if you choose to apply, your information will be treated in accordance with the Kelly Services Privacy Statement.

      Candidate-se através do website

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