Job Description
This job is responsible for performing activities related to research projects.
Key Roles & Responsibilities
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.
Job Requirements and Qualifications
1. Education Requirements
Master’s degree is required
2. Related Field Work Experience
0+ years
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
5. Language Proficiency
Fluency in English
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