Regulatory Officer
psicro
Regulatory Officer
psicro· Regulatory
About this role
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
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 your professional career.
Office-based position
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
- Prior experience with clinical trial submissions is required
- Full working proficiency in English and Serbian
- 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
We are currently looking for a knowledgeable, self-motivated and proactive person to join our Regulatory Affairs Department at PSI Serbia.
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Frequently Asked Questions
Is the salary disclosed for the Regulatory Officer position at psicro?
The salary for this 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 Regulatory Officer position at psicro located?
This Regulatory Officer role at psicro is based in Belgrade, , Serbia. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Officer role at psicro full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Officer role in the Regulatory department at psicro.
Which team or department does the Regulatory Officer at psicro belong to?
This 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 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 Regulatory Officer job at psicro posted?
This Regulatory Officer position at psicro was posted on Sep 28, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Officer
psicro
You'll be redirected to psicro's official application page on SmartRecruiters.