Regulatory and Site Start-Up Specialist

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

📋 Description

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

• Preparation of Clinical Trial Application Forms, along with the creation of submission dossiers for Competent Authorities, Ethics Committees, and other relevant local entities in compliance with local regulations and deadlines.

• Liaise with Competent Authorities and Ethics Committees for study-related purposes and manage responses effectively.

• Provide consistent updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead.

• Maintain project plans, trackers, and regulatory intelligence tools pertinent to assigned duties.

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

• Collaborate with the assigned site CRA to ensure coherent communication regarding site review and management of essential documents necessary for site activation and IMP release.

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

• Oversee and coordinate the translation of documents as needed.

• Keep open lines of communication with other key functions involved in the country start-up process.

• Serve as a Subject Matter Expert in the collection and maintenance of critical path data points related to Site Activation.

• Engage in and support the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designated department.

• Stay informed about local clinical trial laws and regulations, and facilitate knowledge sharing within PFM.

• Ensure audit and inspection readiness at all times by organizing documents in accordance with the TMF plan and/or study-specific plans.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field (preferably in a scientific or healthcare discipline).

• Registered Nurse (RN) or a suitable combination of education, training, and experience.

• A qualification in Pharmacy or relevant work experience as a Pharmacist is highly advantageous.

• 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 abilities.

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

• Proficient in English.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Professional development opportunities