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.

Description

• 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.

Profile

• 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.

Job Offer

• 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