Regulatory and Site Start Up Specialist

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

📋 Description

• Ensure timely and high-quality readiness for site activation within assigned countries/sites while anticipating and addressing potential risks.

• Prepare Clinical Trial Application forms and submission documents for Competent Authorities, Ethics Committees, and other local entities.

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

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

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

• Prepare or assist in the development of study-specific start-up plans, IMP release requirements, and criteria for reviewing essential documents.

• Collaborate with the assigned site CRA on communication and site readiness.

• Oversee the collection and review of essential documents necessary for site activation/IMP release.

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

• Manage document translations.

• Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Keep track of critical-path data for site activation, including authority and ethics timelines, contracts, and budget negotiations.

• Assist in study budget negotiations and the execution of investigator contracts as needed.

• Support outreach for feasibility sites.

• Stay informed on local clinical trial laws and regulations, sharing regulatory knowledge within the organization.

• Ensure readiness for audits/inspections and organize documents according to TMF and study-specific plans.

• Assist with Pre-Study Site Visits when necessary.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN), or a comparable combination of education, training, and experience.

• Qualification in Pharmacy or experience working as a Pharmacist is highly advantageous.

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

• Excellent communication and organizational skills.

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

• Fluency in English is required.

• Preferred experience in regulatory and site start-up processes.

• 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 are recognized and valued for their contributions.

• Employee input and ideas are encouraged and appreciated, fostering positive change within the company.

• Reasonable accommodations are available during the application process for individuals with disabilities.