Regulatory and Site Start Up Specialist

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

📋 Description

• Accountable for the timely and quality delivery of site activation readiness within the designated countries/sites, while anticipating and mitigating any associated risks.

• Responsible for the preparation of Clinical Trial Application Forms and the compilation of submission dossiers (including initial submissions and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other relevant local entities, adhering to local requirements and timelines to secure all necessary authorizations/approvals for the execution of Clinical Trials in accordance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with Competent Authorities and Ethics Committees for study-related purposes and manage responses from these entities.

• Provide regular updates on submissions to the Start-Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team.

• Maintain project plans, project trackers, and regulatory intelligence tools relevant to assigned responsibilities to keep Regulatory Leadership informed.

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

• Collaborate with the assigned site CRA to ensure effective communication, secure site review, and manage the collection of essential documents needed for site activation and IMP release.

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

• Oversee and facilitate the translation process and coordination of document translations.

• Maintain communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and the Site Contracts management group regarding project-specific status and deliverables.

• Serve as a Subject Matter Expert for the collection and maintenance of critical path data points related to Site Activation, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, budget negotiations, and other necessary reviews to ensure timely site activation for assigned sites within the country.

• When necessary, participate in or support negotiations of study budgets and the execution of investigator contracts under the direction of the Site Contract Management department or designated department.

• May assist the feasibility group in outreach to assess potential interest from investigators for a prospective study.

• Keep abreast of local clinical trial laws and regulations, while helping to disseminate this knowledge within PFM to ensure compliance with international and local/national regulations in the conduct of Clinical Trials.

• Maintain audit/inspection readiness consistently and file documents according to the TMF plan and/or study-specific plans within the relevant TMF.

• May support the clinical team during Pre-Study Site Visits.

⛳️ Requirements

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

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

• At least 1 year of experience as a Regulatory or Start-Up specialist (or in a comparable role) within either a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational abilities.

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

• Fluent in English.

🏝️ Benefits

• Health insurance

• Professional development opportunities