Country Approval Specialist (SSU)

Country Approval Specialist (SSU)

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.

Work condition: (1) Fully Remote (2) Hybrid (3) Fully Office Gangnam, Seoul

Team: Country Approval Team

What will you do?

• Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
• Prepares, review 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 ad...

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