Senior Regulatory And Start Up Specialist (Clinical Research)

TL;DR

Senior Regulatory and Start Up Specialist (Clinical Research): Managing site activation readiness and regulatory submissions for clinical trials in Turkey with an accent on local compliance, ethics committee interactions, and cross-functional coordination. Focus on driving country-level submission processes, ensuring audit readiness, and mentoring staff on local regulatory frameworks.

Location: Must be based in Turkey (Remote)

Company

hirify.global is a global Clinical Research Organization specializing in precision medicine, oncology, and rare diseases.

What you will do

• Drive country-level clinical trial submissions and site activation processes.
• Prepare and manage submission dossiers for Competent Authorities and Ethics Committees.
• Coordinate with cross-functional teams including Feasibility, Clinical Operations, and Project Management.
• Maintain project trackers, regulatory intelligence tools, and audit readiness.
• Customize patient information sheets and informed consent forms for local requirements.
• Mentor junior staff on local regulations and internal start-up procedures.

Requirements

• Bachelor’s degree in life sciences, healthcare, or equivalent.
• Minimum 5 years of experience as a Regulatory or Start-Up specialist in a CRO or pharmaceutical industry.
• Fluency in English and Turkish is required.
• Strong knowledge of ICH-GCP guidelines and local clinical trial regulations.
• Experience in driving cross-functional activities and team oversight.
• Proficiency in computerized information systems and milestone tracking tools.

Nice to have

• Advanced degree (MD, PhD, PharmD) or RAC certification.
• Experience in country set-up and site contract negotiations.

Culture & Benefits

• Opportunity to contribute to groundbreaking cancer therapies.
• Collaborative environment where employee input is valued.
• Support for professional growth and development within a global organization.