Regulatory and Start Up Specialist, Fluent in Hungarian

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

📋 Description

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

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

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

• Provide updates on submissions to Start Up/Regulatory Leads and Project Managers/Project Teams.

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

• Prepare or assist in creating study-specific start-up plans, requirements for IMP release, and criteria for essential document review.

• Collaborate with the assigned site CRA to manage the collection of essential documents needed for site activation and IMP release.

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

• Oversee the coordination of document translations.

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

• Maintain critical path data and Site Activation metrics at the site level.

• Assist in study budget negotiations and the execution of investigator contracts as needed.

• Support feasibility site outreach and conduct pre-study site visits when required.

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

• Ensure audit/inspection readiness by organizing and filing documents according to TMF and study-specific guidelines.

⛳️ Requirements

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

• Proven experience as a Regulatory or Start Up specialist, with comparable experience in CRO, pharmaceutical, or biotech settings, or equivalent relevant qualifications and competencies.

• Proficiency in Hungarian.

• Excellent communication and organizational abilities.

• Familiarity with computerized information systems, electronic spreadsheets, word processing software, and email communication.

• Proficiency in English.

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

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

• Experience with milestone tracking tools or systems is a plus.

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

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness programs.

• Flexible working hours and a supportive work environment.