Regulatory and Start Up Specialist

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

📋 Description

• Ensure timely and high-quality readiness for site activation across designated countries/sites while identifying or 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, managing responses effectively.

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

• Maintain project plans, tracking tools, and regulatory intelligence resources.

• Assist with study-specific start-up strategies, IMP release requirements, and criteria for reviewing essential documents.

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

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

• Organize document translations as necessary.

• Facilitate communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Keep track of critical-path data for site activation, including timelines for authorities and ethics, contracts, and budget needs.

• Assist in negotiating study budgets and executing investigator contracts when necessary.

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

• Stay updated on local clinical trial laws and regulations, ensuring audit/inspection readiness and proper TMF filing.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related discipline, or a Registered Nurse (RN), or a comparable 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 sector, or equivalent relevant experience/skills.

• Proficiency in Romanian, Hungarian, and English for applicants from Romania.

• Excellent communication and organizational abilities.

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

• Fluency in English is required.

• A pharmacy qualification or experience working as a pharmacist is highly advantageous.

• Preferred experience in regulatory and site start-up processes.

• Experience with milestone tracking tools/systems is preferred.

• An advanced medical/life sciences degree, 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 insurance and wellness programs.

• Flexible working hours and potential remote work options.

• Supportive and inclusive work environment.