JOB DETAILS

Regulatory Officer / Senior Regulatory Officer

CompanyPSI CRO
LocationTbilisi
Work ModeOn Site
PostedApril 17, 2026
About The Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
About the Role

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals.  We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.

    Job Description

    Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in developing your professional career.

    Full-time, office-based in Tbilisi, Georgia

    Your role:

    • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
    • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
    • Review translations of essential documents subject to clinical trial submission
    • Track the regulatory project documentation flow
    • Review documents to greenlight IP release to sites
    • Manage safety reporting to authorities
    • Deliver regulatory training to project teams
    • Assist with feasibility research and business development requests

    Qualifications

    • College/University degree or an equivalent combination of education, training and experience
    • Life Science degree is a plus
    • Prior experience with clinical trial submissions and/or marketing authorizations/registration of medicinal products
    • Clinical trial industry experience is a plus
    • Full working proficiency in English and Georgian
    • Strong organizational skills with the ability to manage multiple projects simultaneously
    • Excellent time management skills and ability to meet tight deadlines
    • Ability to interpret and apply complex regulatory guidelines
    • Communication, collaboration, and problem-solving skills

    Additional Information

    If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. Our Regulatory team is highly responsive, supportive, and flexible, always striving to deliver a standout service experience for both internal and external customers.

    Please submit your CV in English.

    Key Skills
    Clinical trial submissionsRegulatory affairsEthics submissionsRegulatory documentationSafety reportingProject managementTime managementCommunicationCollaborationProblem-solvingRegulatory guidelinesDocument reviewImport and export licensing
    Categories
    HealthcareScience & ResearchAdministrativeLegal
    Job Information
    📋Core Responsibilities
    The Regulatory Officer will prepare clinical trial submission dossiers for regulatory and ethics authorities and manage the regulatory project documentation flow. They will also communicate with project teams and vendors while ensuring compliance with safety reporting and regulatory guidelines.
    📋Job Type
    full time
    📊Experience Level
    2-5
    💼Company Size
    2848
    📊Visa Sponsorship
    No
    💼Language
    English
    🏢Working Hours
    40 hours
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