Regulatory and Site Start-Up Specialist

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

📋 Description

• Ensure site activation readiness is achieved on schedule and meets quality standards across assigned countries/sites, while identifying and mitigating risks.

• Prepare Clinical Trial Application Forms and submission packages for Competent Authorities, Ethics Committees, and other relevant local entities.

• Engage with Competent Authorities and Ethics Committees, managing their responses effectively.

• Provide submission updates to Start Up/Regulatory Leads and the Project Manager/Project Team.

• Maintain project timelines, trackers, and tools for regulatory intelligence.

• Prepare or assist in developing study-specific start-up plans, requirements for IMP release, and criteria for essential document review.

• Collaborate with the assigned site CRA to ensure effective communication and secure site reviews.

• Oversee the collection and management of essential documents for site activation and IMP release.

• Tailor Patient Information Sheets and Informed Consent Forms to meet country/site-specific requirements.

• Coordinate document translations and manage translation activities efficiently.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding progress and deliverables.

• Serve as a subject matter expert on critical-path data points at the site level, including timelines for authorities and ethics committees, site contracts, budget negotiations, and necessary reviews.

• Assist in negotiations related to study budgets and the execution of investigator contracts as needed.

• Support feasibility outreach to gauge investigator interest in potential studies.

• Keep abreast of local clinical trial laws and regulations, sharing insights within PFM.

• Ensure audit/inspection readiness and file documents in accordance with TMF or study-specific protocols.

• Aid clinical teams during Pre-Study Site Visits.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field (preferably in a scientific or healthcare discipline), or a Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.

• A qualification in Pharmacy or experience as a Pharmacist would be extremely advantageous.

• At least 1 year of experience as a Regulatory or Site Start-Up specialist (or a similar role) within a CRO or the pharmaceutical/biotech sector, or equivalent relevant experience and/or demonstrated skills.

• Excellent communication and organizational abilities.

• Proficient in using computerized information systems, electronic spreadsheets, word processing, and electronic mail.

• Fluent in English.

• Relevant experience in regulatory and site start-up preferred.

• Familiarity with milestone tracking tools/systems is preferred.

• Ability to prioritize tasks effectively to meet deadlines is preferred.

• An advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science is preferred.

🏝️ Benefits

• Employees feel valued for their contributions.

• Suggestions and ideas are recognized and encouraged, leading to positive changes within the company.

• An Equal Opportunity Employer.

• Reasonable accommodations are available throughout the application process.