Country Approval Specialist – Regulatory Submissions

About the role

Join the global regulatory team at PPD as a Country Approval Specialist. You will support the preparation, review and coordination of country‑specific regulatory submissions in line with the global strategy for clinical trials across multiple countries.

Key responsibilities

• Prepare, review and coordinate local regulatory submissions (Ministry of Health, Ethics Committee, gene‑therapy approvals, import licences, etc.) under guidance.
• Provide local regulatory strategy advice to internal clients.
• Act as the key contact at country level for ethical or regulatory submission activities.
• Coordinate with internal functional departments to align site start‑up activities with submission timelines and achieve target cycle times.
• Support start‑up CRA(s) in preparing regulatory compliance review packages.
• Develop country‑specific Patient Information Sheets and Informed Consent forms.
• Maintain trial status information in PPD tracking databases and ensure proper filing of study documents.

Required profile

• Bachelor’s degree or equivalent with relevant academic or vocational qualification.
• At least 2 years of experience in regulatory submissions or related functions within the pharmaceutical/biotech sector.
• Knowledge of local regulatory requirements (MoH, EC) and ability to interpret SOPs and guidelines.

Required skills