인재풀 - Country Approval Specialist (SSU)

Position Overview

• Location Type: Fully Remote, Hybrid, Fully Office (Gangnam, Seoul)
• Job Type: Full-time
• Work Schedule: Not specified
• Employment Type: Full time

This is an evergreen talent pool position for the second half of 2025. Applicants will have priority for interviews for regular positions.

Notification and Consent Regarding Talent Pool Registration

When you register for the talent pool, your personal information may be collected and used for the following purposes in accordance with Articles 15 and 22 of the Personal Information Protection Act:

• Providing recruitment-related information.
• Sending newsletters.

About the Team

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Responsibilities

• Manages the preparation, review, and coordination of Country Submissions in line with global submission strategy.
• Prepares, reviews, and coordinates local regulatory submissions (EC, additional special national local applications if applicable, e.g., gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develops and implements local submission strategy.
• Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as the primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Ensures guidelines and processes are followed for effective internal PPD team communications, as well as communications with investigators and country regulatory authorities to ensure submissions are managed in a timely manner.
• Acts as a key contact at the country level for all submission-related activities.
• Participates as required in Submission Team Meetings, Review Meetings, and Project Team meetings.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
• Ensures alignment of submission process for sites and study to the critical path for site activation.
• Achieves PPD’s target cycle times for site activations.
• Prepares the regulatory compliance review packages, as applicable.
• Liaises within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develops country-specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets and payment schedules negotiations with sites.
• Assists in identifying and recognizing local out-of-scope activities in a contract in a timely manner and advises relevant functions.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensures that trial status information relating to SIA activities is accurately maintained in the database and is current at all times.
• Oversees country study files and ensures that they meet PPD WPD’s or client SOP’s.
• Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Directs/mentors other SIA individuals assigned to support projects of responsibility, as appropriate.
• Proactively identifies issues or anomalies in the regulatory process of a study, resolves or escalates as appropriate.

Qualifications

• Education and Experience: Bachelor's degree or equivalent.