Regulatory and Site Start-Up Specialist
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Job Description
Regulatory and Site Start-Up Specialist supporting clinical trial submissions and site activation in Taiwan. Coordinating authorities, ethics committees, essential documents, and cross-functional study teams.
Responsibilities:
- Deliver site activation readiness on time and to quality standards within assigned country/sites, while foreseeing and mitigating risks
- Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide updates on submissions to Start Up/Regulatory Leads and the Project Manager/Project Team
- Maintain project plans, project trackers, and regulatory intelligence tools
- Prepare or support study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with assigned site CRA to align communication and secure site review
- Review and manage collection of essential documents for site activation/IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Facilitate document translations and coordinate translation activities
- Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables
- Act as subject matter expert for site-level critical-path data points, including authority and ethics committee timelines, site contracts, budget negotiations, and required reviews
- Support study budget negotiations and investigator contract execution when required
- Support feasibility outreach to assess investigator interest in potential studies
- Maintain current knowledge of local clinical trial laws and regulations and share knowledge within PFM
- Maintain audit/inspection readiness and file documents according to TMF or study-specific plans
- Support clinical teams performing Pre-Study Site Visits
Requirements:
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
- A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial
- 1 year or more as a Regulatory or Site Start-Up specialist (or comparable role) in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Strong communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
- Fluency in English
- Relevant regulatory and site start-up experience preferred
- Experience using milestone tracking tools/systems preferred
- Ability to prioritize workload to meet deadlines preferred
- Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred
Benefits:
- Employees feel appreciated for their contributions
- Input and ideas valued and nurtured, impacting positive change for the company
- Equal Opportunity Employer
- Reasonable accommodation available during the application process
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