Regulatory and Start Up Specialist

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

📋 Description

• Accountable for ensuring the timely and high-quality delivery of site activation readiness within designated countries/sites while identifying and mitigating potential risks.

• Responsible for the preparation of Clinical Trial Application Forms and the submission dossier (initial and amendments/notifications) to Competent Authorities, Ethics Committees, and other relevant local entities, adhering to local requirements and timelines to secure all necessary authorizations/approvals for conducting 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 matters and manage responses to these bodies.

• Provide regular updates regarding the 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, trackers, and regulatory intelligence tools related to assigned duties, keeping Regulatory Leadership informed.

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

• Collaborate with the assigned site Clinical Research Associate (CRA) to ensure effective communication and manage the collection of essential documents needed for site activation/IMP release.

• Tailor the Patient Information Sheet and Informed Consent Form to meet country/site-specific needs.

• Oversee and facilitate the translation 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 Site Contracts management, regarding project-specific status and deliverables.

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

• When necessary, assist in negotiating study budgets and executing investigator contracts under the guidance of the Site Contract Management department or its designee.

• May participate in supporting the feasibility group with site outreach to gauge potential investigator interest in a study.

• Stay updated on local clinical trial laws and regulations, sharing this knowledge within PFM to ensure Clinical Trials are conducted in compliance with both international and local/national regulations.

• Maintain audit/inspection readiness at all times and organize documents according to the Trial Master File (TMF) plan and/or study-specific plans within the relevant TMF.

• May assist the clinical team with Pre-Study Site Visits.

⛳️ Requirements

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

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

• Proven experience as a Regulatory or Start-Up specialist (or in a similar role) within a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational skills.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing software, and electronic mail is essential.

• Fluency in English is required.

🏝️ Benefits

• Health insurance

• Retirement plans

• Professional development