Regulatory & Site Activation Specialist

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

📋 Description

• Collaborate with SAR colleagues to strategize, organize, compile, track, and ensure timely submission of regulatory documents with consistently high standards.

• Serve as the primary contact for the review of translation for submission materials, including applications, synopses, informed consent forms (ICFs), and labels.

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

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

• Assess relevant documentation such as labels, patient information sheets, and diary cards, providing recommendations for changes to adhere to ICH GCP and country-specific regulations.

• Establish and cultivate relationships with local investigators and key personnel at sites.

⛳️ Requirements

• A minimum of a four-year degree with a major in medical, biological, physical, health, pharmacy, or other related scientific fields.

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

• Prior experience within the pharmaceutical or CRO sectors.

• Comprehensive understanding of ICH GCP and other pertinent guidelines for conducting clinical research.

• Experience with regulatory submissions in Taiwan.

• Excellent organizational and time management capabilities.

• Strong aptitude for planning, strategizing, managing, monitoring, scheduling, and evaluating.

• Exceptional written and verbal communication skills in both English and the local language.

• Ability to manage multiple tasks effectively in a dynamic and fast-paced environment.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Strong awareness of country-specific cultural norms and local healthcare systems.

• Multilingual candidates are preferred.

🏝️ Benefits

• Equal employment opportunities.

• A diverse and inclusive work environment.

• Supportive and collaborative team culture.

• Accessible leadership.

• Employee experiences that prioritize respect and equal opportunity for all.