Regulatory Affairs Manager

Lisbon Indefinido Consultar descrição da função
This role integrates Technical Direction, Pharmacovigilance and Regulatory Affairs, ensuring full compliance with local and European regulations across the pharmaceutical product lifecycle. It serves as the main liaison with health authorities and guarantees the quality, safety and regulatory integrity of all activities.

Added 29/06/2026

  • This role offers an excellent opportunity for professional growth.
  • Joining this company will allow you to contribute to impactful project.

Sobre o nosso cliente

The company is an international biopharmaceutical organization focused on developing innovative treatments in specialized care. It operates in areas such as Oncology, Rare Diseases and Neuroscience, using strong scientific and research expertise to address important unmet medical needs.

Descrição

  • Ensure compliance with GDP/GxP requirements, manage the Quality Management System, oversee audits, product release, complaints and recalls.
  • Lead local pharmacovigilance activities, including adverse event reporting, safety monitoring and maintaining inspection readiness.
  • Manage regulatory submissions and lifecycle activities, including marketing authorizations, variations and renewals.
  • Act as the main contact point with national health authorities, supporting inspections and ensuring regulatory alignment.
  • Review and approve promotional and non-promotional materials in line with local regulations and ethical standards.
  • Collaborate across functions and with external partners to ensure compliance, provide training and drive continuous improvement.

Perfil ideal

  • Degree in Pharmaceutical Sciences, with additional specialization in Regulatory Affairs, Quality, or Pharmacovigilance considered an advantage.
  • Proven experience in Regulatory Affairs, Pharmacovigilance and/or Quality/Technical Director roles within the pharmaceutical industry.
  • Strong knowledge of GDP, GVP, GCP and the pharmaceutical product lifecycle.
  • Experience interacting with health authorities and managing inspections and audits.
  • Strong analytical, organizational and communication skills, with the ability to manage complexity and multiple priorities.
  • Fluent in Portuguese and English, with high attention to detail, integrity and a collaborative mindset.

Vantagens

  • Attractive benefits package aligned with the responsibility of the role.
  • Integration into a growing organization, which invests in continuous development, with access to specialized training, professional support and real opportunities for progressio
Pesquise mais Ofertas
Pedro Borges Caroço
Quote job ref
JN-062026-7041958

Resumo da Função

Setor
Healthcare & Life Sciences
Subsetor
Assuntos Regulamentares
Adicionar indústria
Healthcare / Pharmaceutical
Localização
Lisbon
Tipo de contrato
Indefinido
Nome do Consultor
Pedro Borges Caroço
Referência da Oferta
JN-062026-7041958

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