Regulatory Officer
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About the role
Office-based Regulatory Officer role in Belgrade, Serbia, supporting clinical trial regulatory and ethics submissions, import/export license applications, authority and committee communications, document review, safety reporting, training, and feasibility or business development requests. A college/university degree or equivalent education, training and experience, prior clinical trial submission experience, English and Serbian proficiency, and MS Office proficiency are required.
Key requirements
- • College/University degree or an equivalent combination of education, training and experience
- • Required skills: Clinical trial submission dossier preparation, Regulatory and ethics authority submissions, Import and export license applications, Communication with regulatory authorities and ethics committees, Reviewing translations of essential clinical trial documents, Regulatory project documentation tracking, IP release document review, Safety reporting to authorities, Regulatory training delivery, Feasibility research, Business development support, MS Office applications, English language proficiency, Serbian language proficiency, Communication, Collaboration, Problem-solving, Planning, Working in a dynamic team environment, Attention to detail, Prior experience with clinical trial submissions
- • Required languages: English, Serbian
Opportunity details
- • Workplace: On Site
- • Posted: Sep 28, 2026
- • Original advert language: English
Full vacancy
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See original vacancy ↗Employer’s role description
Job title: Regulatory Officer
Location: Belgrade, Serbia
Employment type: Full-time
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.
Verification
- ✓ Employer verification
- ✓ Original posting located
- Last verified: Sep 29, 2026