Country Approval Specialist

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

📋 Description

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

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

• Provide and oversee project-specific local SIA services.

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

• Serve 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 for sites and studies are in line with the critical path for site activation.

• Meet PPD’s target cycle times for site submissions.

• Work with start-up CRAs to compile regulatory compliance review packages when applicable.

• Create country-specific Patient Information Sheet/Informed Consent Form documents as needed.

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

• Support feasibility activities in accordance with established timelines.

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

• Prepare, set up, and maintain local country study files and filing processes per PPD WPDs or relevant client SOPs.

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

⛳️ Requirements

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

• Prior experience that equips you with the knowledge, skills, and abilities to perform the job (approximately 2+ years).

• In certain instances, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient to fulfill the role's requirements.

• Proficient oral and written communication skills.

• Exceptional interpersonal skills.

• Strong attention to detail and quality in documentation.

• Effective negotiation skills.

• Competent computer skills with the ability to learn relevant 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 or independently, as directed.

• Fundamental organizational and planning skills.

• Basic knowledge of all relevant regional/national country regulatory guidelines and EC regulations.

• Work is conducted in an office/laboratory and/or clinical setting.

• Exposure to biological fluids with the potential for contact with infectious organisms.

• Interaction with electrical office equipment.

• Personal protective equipment such as eyewear, garments, and gloves is required.

🏝️ Benefits

• Comprehensive health benefits.

• Opportunities for professional development and training.

• Flexible working arrangements.

• Competitive salary and performance-based incentives.