Regulatory Affairs Manager

Full-time Gestão e operações

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.

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.

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 act...