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Responsibilities Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients Provides project specific local SIA services a

Lifelancer is a talent-hiring platform serving the life sciences, pharmaceutical, and IT sectors. The FSP Country Approval Specialist supports the preparation, review, coordination, and management of local regulatory and ethics submissions for clinical trials. The role also coordinates site start-up activities, maintains study documentation and tracking databases, and provides country-level submission support. Respon