1. Register new products and maintain the regulatory approval with an optimal plan
- Set-up registration strategy and update milestone plan on a regular basis
- Compile and submit the application for marketing approval and maintenance of product licenses
- Estimate and evaluate regulatory environment or requirements and take appropriate action for registration and product maintenance.
2. Register the clinical trial of new drug with local and global strategy
3. Monitor routinely the regulatory environment and to implement in a timely manner or spread out to the responsible department if necessary
4. Review product labeling and packing material in compliance with local regulation and approve it
5. Support Head of Regulatory Affairs Korea to achieve the medical and regulatory strategic objectives as a member of medical management team.
1. Background: Pharmacist, chemist, biologist or equivalent
2. Education: minimum 4-year university
3. Experience: minimum 2-3 years in healthcare industry, preferably Regulatory Affairs Associate
- Profound knowledge of regulations and its requirements
- Executive ability to produce highly qualified applications
- Good communication and negotiation skills
- Good command of English communication skills
- Good understanding of pharmaceutical science