Regulatory Officer
Regulatory Officer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products while taking a step further in your professional career.
Officebased in Seoul
Your role:
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities including Import and Export license applications
- Communicate with regulatory authorities ethics committees project teams and vendors on regulatoryrelated matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
- Manage safety reporting to authorities
- Deliver regulatory training to project teams
- Assist with feasibility research and business development requests
Qualifications :
- College/University degree or an equivalent combination of education training and experience
- At least 3 to 5 years of prior experience with clinical trial submissions in Korea
- Full working proficiency in English and Korean
- Proficiency in MS Office applications
- Detailoriented
- Ability to learn plan and work in a dynamic team environment
- Communication collaboration and problemsolving skills
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
