Country Approval Specialist – FSP

This is a fully remote position, open to applicants in Greece.

📋 Description

• Prepare, assess, and coordinate local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategy advice to internal clients with appropriate guidance.

• Provide and manage project-specific local SIA services.

• Reach out to investigators for activities related to submissions as required.

• Act as the primary country-level contact for ethical or regulatory submission-related tasks.

• Collaborate with internal functional departments on site initiation activities, submission coordination, and timelines.

• Meet PPD target cycle times for sites.

• Work alongside start-up CRAs to prepare regulatory compliance review packages as necessary.

• Create country-specific Patient Information Sheets and Informed Consent forms as required.

• Assist in negotiating grant budgets and payment schedules with sites.

• Support feasibility activities based on agreed timelines.

• Enter and update trial status information for SIA activities in PPD tracking databases.

• Prepare, organize, and maintain local country study files and filing systems.

• Stay informed about PPD SOPs, client SOPs/directives, and relevant regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Over 2 years of relevant experience, or a suitable combination of education, training, and directly related experience.

• Strong oral and written communication abilities.

• Excellent interpersonal skills.

• High attention to detail and quality of documentation.

• Proficient negotiation skills.

• Competent computer skills and the ability to learn necessary software.

• Good command of the English language and grammar.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Capability to work collaboratively in a team environment or independently with direction.

• Basic organizational and planning abilities.

• Fundamental knowledge of relevant regional/national regulatory guidelines and EC regulations.

🏝️ Benefits

• Full-time employment.

• Reasonable accommodations for individuals with disabilities.

• Equal opportunity employment.