Country Approval Specialist (EMEA)

About the role

Join a leading global team that supports top pharmaceutical companies and biotech firms in delivering clinical trials across more than 100 countries. As a Country Approval Specialist you will manage and coordinate local regulatory submissions, ensuring alignment with the global submission strategy and timely site activation.

Key responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, special applications such as gene‑therapy approvals, viral safety dossiers, import licences).
• Provide local regulatory strategy advice to internal clients under guidance.
• Act as the key contact at country level for ethical and regulatory submission activities.
• Coordinate with internal functional departments to align site start‑up activities with submission timelines.
• Maintain trial status information in PPD tracking databases and ensure proper filing of country study files.
• Support feasibility activities, grant budget negotiations and development of country‑specific patient information sheets or informed consent forms.

Required profile

• Bachelor’s degree or equivalent with relevant academic/vocational qualification.
• Minimum of 2 years of experience in regulatory affairs, clinical trial start‑up or related fields.
• Strong knowledge of local regulatory guidelines, SOPs and submission processes.

Required skills

What we offer

• Opportunity to work on high‑impact clinical trials for leading pharma and biotech companies.
• Collaborative global environment with professional development support.