Lead planning and execution of Clinical Trial Application (CTA) submissions
Serve as local subject matter expert on CTA regulations and submission processes
Support MFDS interactions throughout CTA review and approval
What they want
Minimum 9 years of experience in Regulatory Affairs with CTA submission expertise
Bachelor's degree in life science or pharmacy
Strong knowledge of local and global CTA regulations,hands-on MFDS submission experience
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Seoulstart's read
Visa tier (likely)
E-7 specialty / professional (likely)
Korean language
Korean requirement not stated
English friendliness
Medium: English JD, mixed-language workplace
Context
Requires 9+ years of hands-on MFDS submission experience,so despite no stated Korean-language bar,this is a senior local specialist role,not an entry point for newcomers to Korea's regulatory system.
This is Seoulstart's analysis of the public job description, not the employer's stated policy. Verify visa sponsorship, language requirements, and remote allowances directly with the recruiter.