Regulatory Submissions & Contract Specialist (Dual Role)

About the role

We are looking for a full‑time, home‑based Regulatory Submissions Coordinator and Contract Specialist to join our Clinical Operations team in Georgia. The dual role supports regulatory submissions to authorities and ethics committees as well as contract negotiations for clinical studies.

Key responsibilities

• Prepare, review and file initial clinical trial applications to regulatory authorities and ethics committees in Georgia.
• Submit responses to queries, amendments and ensure compliance with regulations and guidance documents.
• Maintain the Clinical Trial Management System and ensure timely filing of essential documents.
• Draft, review, negotiate and finalize agreements, termination letters and other legal documents for clinical studies.
• Identify and assess legal, financial and operational risks and escalate to the Contract Lead or Manager.
• Coordinate with internal functional departments to align site startup activities with contractual timelines.

Required profile

• Bachelor’s degree, preferably in Life Sciences or Law.
• Experience preparing, reviewing and submitting regulatory documentation to ethics committees and regulatory agencies.
• Previous work at a CRO, pharmaceutical company or investigative site.
• Knowledge of local Georgian regulatory guidelines and legislation.
• Excellent organizational, prioritization and communication skills.
• Fluency in Georgian and English.

What we offer

• Competitive compensation recognizing performance.
• Comprehensive health, wellness, retirement and paid‑time‑off benefits.
• Office‑based environment with occasional remote work flexibility after training.
• Mentorship, clear career paths and continuous professional development.
• Company‑sponsored social events and a collaborative culture.