Regulatory and Start Up Specialist – Fluent in Hungarian

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

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

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

• Engage with Competent Authorities and Ethics Committees to manage responses effectively.

• Provide updates on submissions to study leads and project teams.

• Maintain project plans, trackers, and regulatory intelligence resources.

• Assist with study-specific start-up plans, IMP release criteria, and essential document review standards.

• Collaborate with CRAs to ensure effective communication and gather necessary site activation documents.

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

• Oversee the translation of documents.

• Relay country start-up progress and deliverables to feasibility, clinical operations, project management, regulatory, and site contracts teams.

• Keep site-level critical-path data updated for site activation.

• Aid in negotiations for study budgets and execution of investigator contracts.

• Assist with feasibility site outreach and conduct pre-study site visits.

• Stay informed about local clinical trial laws and regulations.

• Uphold audit/inspection readiness and properly file documents in the relevant TMF.

⛳️ Requirements

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

• 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 capabilities.

• Proficiency in Hungarian.

• Excellent communication and organizational skills.

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

• Proficiency in English.

• Candidates must have legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.