Specialist, Regulatory & Site Activation

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

📋 Description

• Collaborate with SAR colleagues to effectively plan, organize, compile, monitor, track, and timely submit regulatory submissions while ensuring a consistently high standard of quality.

• Serve as a point of contact for the translation review of submission documents including applications, synopses, ICFs, labels, and more.

• Oversee the customization of country-specific patient information sheets and consent forms.

• Manage country-specific drug labeling details and maintain Country Intelligence Pages.

• Assess and provide recommendations on all pertinent documentation, such as labels, patient information sheets, and diary cards, to ensure compliance with ICH GCP and country-specific regulations.

⛳️ Requirements

• Completion of a minimum four-year college program with a major focus on medical, biological, physical, health, pharmacy, or other related sciences.

• At least three years of experience in clinical research, ideally in site activation and/or regulatory functions.

• Prior experience in the pharmaceutical or CRO industry is essential.

• Comprehensive understanding of ICH GCP, EU Clinical Trials Directive, and other relevant guidelines for conducting clinical research.

• Mandatory experience in regulatory submissions in South Korea.

• Multilingual skills are preferred; proficiency in English is required.

🏝️ Benefits

• Flexible working arrangements.

• Opportunities for professional development.