Regulatory and Start Up Specialist, Fluent in Hungarian

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

📋 Description

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

• Create Clinical Trial Application forms and submission packages 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 Start Up/Regulatory Leads and Project Managers/Project Teams.

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

• Develop or assist in the creation of study-specific start-up plans, requirements for IMP release, and criteria for essential document reviews.

• Collaborate with site CRAs to ensure aligned communications and to secure, review, and manage essential documents.

• Customize Patient Information Sheets and Informed Consent Forms as necessary.

• Oversee the coordination of document translations.

• Liaise with teams in Feasibility, Clinical Operations, Project Management, Regulatory, 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 as needed.

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

• Stay updated on local clinical trial laws and regulations.

• Ensure audit/inspection readiness and organize documents in the appropriate TMF.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN), 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 possess equivalent relevant experience and/or demonstrated competencies.

• Proficiency in Hungarian.

• Excellent communication and organizational abilities.

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

• Proficiency in English.

• Candidates must be legally authorized to work in the country of employment without the necessity for employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.