Regulatory and Site Start Up Specialist

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

📋 Description

• Accountable for ensuring the timely and quality delivery of site activation readiness within the designated country/sites, while anticipating and alleviating any potential risks.

• Responsible for the preparation of Clinical Trial Application Forms and submission dossiers (initial and amendments/notifications) for local regulatory bodies including CA and EC, adhering to local requirements and timelines to secure all necessary authorizations for Clinical Trial conduct in accordance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with CA/EC for study-related purposes and manage responses to these authorities.

• Provide regular updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team as necessary.

• Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities, ensuring Regulatory Leadership remains informed.

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

• Collaborate with the assigned site CRA to guarantee consistent communication and foster site cooperation.

• Prepare, review, and manage the collection of essential documents required for site activation and IMP release.

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

• Oversee the translation and coordination of translations for documents necessary for submission.

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

• Serve as a Subject Matter Expert (SME) in the collection and maintenance of site-level critical path data points for Site Activation, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements to ensure timely site activation for assigned sites in the country.

• When necessary, support the negotiation of study budgets and the execution of investigator contracts under the direction of the Site Contract Management department/designee.

• May assist the feasibility group in reaching out to potential investigators to gauge their interest in a study.

• Stay updated on local clinical trial laws and regulations, disseminating knowledge within PfM to ensure compliance with international and local/national regulations during Clinical Trials.

• Maintain audit and inspection readiness at all times, organizing documents in accordance with the TMF plan and/or study-specific plans within the relevant TMF.

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

• May contribute to process improvement initiatives, training, and mentoring.

• Perform other duties as assigned by management.

⛳️ Requirements

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

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

• Excellent communication and organizational skills are crucial.

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

• Fluency in English is required, and for non-English speaking countries, proficiency in the local language of the country where the position is based.

🏝️ Benefits

• Health insurance

• Flexible working hours

• Professional development opportunities