Regulatory and Start Up Specialist, Fluent in Hungarian

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

📋 Description

• Ensure prompt and high-quality readiness for site activation across designated countries and sites, while identifying and addressing potential risks.

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

• Engage with Competent Authorities and Ethics Committees, managing their responses effectively.

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

• Maintain project schedules, trackers, and tools for regulatory intelligence.

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

• Collaborate with assigned site CRAs to organize the collection of essential documents necessary for site activation and IMP release.

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

• Oversee the translation of documents.

• Interact with teams involved in feasibility, clinical operations, project management, regulatory affairs, and site contracts.

• Maintain critical-path data at the site level for activation purposes.

• Assist in negotiations related to study budgets and the execution of investigator contracts when necessary.

• Support outreach efforts and feasibility assessments for sites.

• Stay updated on local laws and regulations pertaining to clinical trials.

• Ensure readiness for audits and inspections, filing documents in accordance with TMF and study-specific guidelines.

• Assist with Pre-Study Site Visits as required.

⛳️ Requirements

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

• Proven experience as a Regulatory or Start-Up specialist, in a comparable role, or possess equivalent relevant experience and/or demonstrated skills.

• Fluency in Hungarian.

• Exceptional communication and organizational abilities.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing software, and email applications.

• Fluency in English.

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

• Prior experience in regulatory affairs and site start-up is preferred.

• Experience utilizing milestone tracking tools/systems is preferred.

• An advanced degree in medical or life sciences, RAC certification, or a Master’s degree in Regulatory Science is preferred.

🏝️ Benefits

• Flexible remote work arrangement.

• Commitment to being an equal opportunity employer.

• Reasonable accommodations available for applicants with disabilities.