Senior Regulatory Officer

psicro· Regulatory
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📍 Prague📍 Prague, Prague, Czechia📍 czFull time

About this 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 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

    Job Description

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

    Hybrid working arrangement in Prague, the Czech Republic

    Your role:

    • Prepare and oversee the preparation of clinical trial submission 
    • Acts as a Regulatory Lead in complex clinical trials and programs of clinical trials: coordination of CTIS submission, shared responsibility for developing global and country-level submission strategy
    • Primary responsibility for discussing submission strategy with sponsors
    • Identifying regulatory risks and working on mitigation plans
    • Managing consistency of approaches and regulatory processes across multiple trials in programs of clinical trials  
    • 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
    • A minimum of 5 year's experience with clinical trial submissions in the Czech Republic (experience in Slovakia is an advantage)
    • Extensive experience with Clinical Trial Information System (CTIS)
    • Full working proficiency in Czech (or Slovak) and English
    • Proficiency in MS Office applications
    • Detail-oriented
    • Ability to learn, plan and work in a dynamic team environment
    • Communication, collaboration, and problem-solving skills

    Additional Information

    Start your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

    Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:

    • Excellent and flexible working conditions.
    • A unique combination of team collaboration and independent work.
    • Competitive salary and benefits package.

    If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.

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    Frequently Asked Questions

    Is the salary disclosed for the Senior Regulatory Officer position at psicro?
    The salary for this Senior Regulatory Officer role at psicro is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
    Where is the Senior Regulatory Officer position at psicro located?
    This Senior Regulatory Officer role at psicro is based in Prague, Prague, Prague, Czechia, cz. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
    Is the Senior Regulatory Officer role at psicro full-time or part-time?
    This is listed as a Full time position. It is posted as a Senior Regulatory Officer role in the Regulatory department at psicro.
    Which team or department does the Senior Regulatory Officer at psicro belong to?
    This Senior Regulatory Officer position is part of the Regulatory department at psicro. See the full job description for more information about the team structure and responsibilities.
    How do I apply for the Senior Regulatory Officer position at psicro?
    Click the "Apply Now" button on this page. You will be redirected to psicro's official application portal hosted on smartrecruiters where you can submit your application directly.
    When was the Senior Regulatory Officer job at psicro posted?
    This Senior Regulatory Officer position at psicro was posted on Oct 2, 2025. Apply as soon as possible — early applications are often reviewed first.
    Senior Regulatory Officer
    psicro
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