European Medicines Quality Program Lead

European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe; Strasbourg; Sur place; EUR 60 000 - 75 000; Plein temps

Avantages offerts par ce poste

Secondment

Relocation allowance

Travel expenses covered

Résumé du poste

European Directorate for the Quality of Medicines and HealthCare (EDQM) seeks professionals to support CEP evaluations, GMP inspections, and regulatory work across its programmes in Strasbourg. Roles involve scientific evaluation, collaboration with authorities, and guidance on dossier requirements within European Pharmacopoeia standards.

The vacancies include secondment opportunities, potential relocation allowances, and travel expenses covered by the Organisation.

Qualifications

• Profile 1 requires at least 3 years’ professional experience in evaluating or compiling the quality part of dossiers for medicines, CTD Module 3.2.S focus.
• Profile 2 requires at least 3 years’ professional experience as an official GMP inspector in a national authority or equivalent.
• Profile 3 requires at least 3 years’ professional experience in evaluating or compiling quality part dossiers or in medicines policy/ international affairs.

Responsabilités

• Profile 1: assess CEP applications and ensure regulatory requirements are respected; prepare reports; communicate with CEP applicants and monitor dossiers.
• Profile 2: perform GMP inspections of manufacturers; prepare inspection reports; communicate findings to manufacturers; follow up on corrective actions.
• Profile 3: support evaluation of CEP applications, oversee GMP inspections, implement new guidelines; collaborate with EDQM colleagues and external experts; communicate with CEP applicants.

Connaissances

English proficiency

French basics

Description du poste

European Directorate for the Quality of Medicines and HealthCare (EDQM) seeks professionals to support CEP evaluations, GMP inspections, and regulatory work across its programmes in Strasbourg. Roles involve scientific evaluation, collaboration with authorities, and guidance on dossier requirements within European Pharmacopoeia standards.

The vacancies include secondment opportunities, potential relocation allowances, and travel expenses covered by the Organisation.