Regulatory Affairs Associate

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Execute feasibility studies, identify sites, negotiate site contracts, and manage other essential SSU operations.

• Offer expertise to the Study Start Up team leaders and project teams, providing valuable insights that promote success.

• Prepare and coordinate submissions to regulatory, ethics, and other pertinent bodies, ensuring adherence to all relevant regulations and guidelines.

• Assist in the creation, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms.

⛳️ Requirements

• A Bachelor's degree or its local equivalent.

• Minimum of 3 years of experience or knowledge of clinical regulatory affairs requirements and activities, including IND submission and the CMC process.

• Proficiency in the local language as well as English is mandatory.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that include medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career advancement pathways.