* 업무 내용 1. Regulatory Intelligence and Trend Analysis Support - Investigate domestic and international regulatory guidelines related to Vaccine development and approval.
- Investigate relevant laws, regulatory authority publications (including guidelines), and recommendations from international organizations (e.g., ICH, WHO).
- Collect scientific evidence and regulatory considerations related to nonclinical, clinical, quality (including manufacturing), and risk management for emerging technologies etc.
2. Expert advisory group operation - Operate an expert advisory group consisting of specialists from industry, academia, research institutes, healthcare institutions, and regulatory authorities.
- Facilitate expert meetings to identify key regulatory issues and review points for guideline development and summarize consensus and differing opinions.
3. Training and seminar organization support - Organize seminars and training sessions with domestic and international experts related to guideline development or revision.
4. Guideline development support - Support preparation of the final guideline draft, incorporating feedback from external stakeholders such as relevant associations and academic societies.
* 자격요건 1. Education Requirements - Master’s degree is required
2. Related Field Work Experience 3. Technical and Professional Skills / Knowledge - Basic knowledge of biology and understanding of biopharmaceutical regulations (Vaccine field is preferred) and familiarity with guideline published by MFDS (Ministry of Food and Drug Safety) etc.
4. Key Competency - Teamwork
- Creativity
- Communication
- Planning & Organizing
- Commitment to Continuous Learning
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