Country Approval Specialist – Regulatory Submissions

About the role

Join PPD’s global regulatory team as a Country Approval Specialist, supporting clinical trial start‑up across the Nordics, UK, Ireland, Spain, Portugal and Italy. You will manage and coordinate local regulatory submissions in line with the global strategy, ensuring timely site activation and compliance.

Key responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, gene‑therapy approvals, import licences, etc.).
• Provide local regulatory strategy advice to internal clients under guidance.
• Act as the key contact for ethical and regulatory submission activities at country level.
• Coordinate with internal functional departments to align site start‑up activities with submission timelines.
• Achieve PPD target cycle times for site activation and support start‑up CRA(s) with compliance packages.
• Develop country‑specific Patient Information Sheets and Informed Consent Forms.
• Assist with grant budget negotiations and feasibility coordination.
• Maintain trial status information in PPD tracking databases and ensure proper study file management.

Required profile

• Bachelor’s degree or equivalent with relevant academic or vocational qualification.
• Minimum of 2 years of experience in regulatory affairs or clinical trial start‑up.
• Strong oral and written communication skills in English.
• Excellent attention to detail and documentation quality.
• Good negotiation abilities and interpersonal skills.

Required skills

• Computer skills and ability to learn specialised software.