Regulatory and Site Start Up Specialist

📋 Description

• Responsible for timely, high-quality site activation in assigned country/sites.
• Prepare Clinical Trial Applications and submission dossiers for authorities/ECs.
• Manage CA/EC interactions and provide regulatory study responses.
• Maintain project plans, trackers, and regulatory TMF tools.
• Develop country/site start-up plans and essential document review criteria.
• Coordinate with site CRAs and translate site documents as needed.

🎯 Requirements

• Bachelor’s degree in life sciences or RN or equivalent.
• 1+ year as Regulatory or Start-Up specialist in CRO/pharma.
• Experience with CA/EC submissions and local regulatory requirements.
• Strong communication and organizational skills; ability to prioritize deadlines.
• Fluency in English; proficiency with electronic systems (MS Office, email).
• Advanced degree (MD/PhD/PharmD) or RAC; regulatory start-up experience preferred.

🎁 Benefits

• Remote work arrangement (Remote, Taiwan).
• Equal Opportunity Employer.
• Opportunity to work on oncology and rare diseases.
• Collaborative, growth-focused team environment.