Country Approval Specialist

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

📋 Description

• Prepare, review, and coordinate local regulatory submissions, which include the Ministry of Health, Ethics Committee, and relevant special national applications.

• Offer local regulatory strategy guidance to internal clients under supervision.

• Provide and coordinate project-specific local SIA services.

• Reach out to investigators for submission-related activities as necessary.

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

• Collaborate with internal functional departments to synchronize site start-up activities and submission timelines.

• Ensure that submission processes align with the critical path for site activation.

• Meet PPD target cycle times for sites.

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

• 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 in accordance with agreed timelines.

• Input and maintain trial status information for SIA activities in PPD tracking databases.

• Prepare, establish, and maintain local country study files and filing processes.

• Stay updated on PPD and client SOPs/directives and applicable regulatory guidelines.

⛳️ Requirements

• A Bachelor’s degree or equivalent formal academic/vocational qualification.

• Prior experience of at least 2 years in a comparable role.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Exceptional attention to detail and quality of documentation.

• Proficient negotiation skills.

• Competent computer skills and a willingness to learn relevant software.

• Proficient English language and grammar skills.

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

• Capability to work both in a team setting and independently, as required.

• Basic organizational and planning abilities.

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

• Willingness and capability to work in an office, laboratory, and/or clinical environment.

• Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment.

• Competence in using necessary personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Comprehensive training and professional development opportunities.

• Competitive salary and performance-based bonuses.

• Health and wellness programs.

• Flexible work environment.

• Opportunities for career advancement.