Senior Start Up & Regulatory Specialist

Location: Remote, Turkey

Company

hirify.global is a clinical research organization supporting precision medicine studies, including rare disease and oncology trials, through clinical operations, medical expertise, biomarker solutions, and data analytics.

What you will do

• Drive country-level regulatory submissions and site activation activities, coordinating assigned specialists and mitigating risks to timelines and quality.
• Prepare clinical trial application forms and submission dossiers for competent authorities, ethics committees, and other applicable local bodies.
• Interact with competent authorities and ethics committees, manage responses, and provide regular submission and activation-readiness updates.
• Prepare, review, and manage essential documents, patient information sheets, informed consent forms, translations, and IMP release requirements.
• Coordinate with Clinical Operations, Project Management, Feasibility, Regulatory, Site Contracts, CRAs, and study teams on country start-up deliverables.
• Maintain regulatory intelligence, project trackers, critical-path data, audit readiness, and documents in the trial master file.

Requirements

• Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification, or an equivalent combination of education, training, and experience.
• At least 5 years of experience as a Regulatory or Start-Up Specialist in a CRO, pharmaceutical, or biotechnology organization.
• Fluency in English and Turkish is required.
• Experience coordinating cross-functional activities, overseeing teams, prioritizing workloads, and meeting deadlines.
• Knowledge of Good Clinical Practice, ICH Guidelines, and applicable local and national clinical trial regulations.
• Strong computer, organizational, communication, presentation, and interpersonal skills, with attention to detail and accuracy.

Nice to have

• Relevant Turkish regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions.
• Experience with country set-up activities and milestone tracking systems.
• Advanced medical or life sciences degree, RAC certification, or a master’s degree in Regulatory Science.
• Experience mentoring junior start-up specialists and supporting process improvement initiatives.

Culture & Benefits

• Remote work arrangement in Turkey.
• Occasional travel may be required.
• Opportunities to contribute ideas and support positive organizational change.
• Work connected to clinical research into cancer therapies, rare diseases, and precision medicine.