Regulatory Officer

PSI CRO·Belgrade, Serbia

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About the role

Hybrid Regulatory Officer role in Belgrade supporting clinical trial regulatory and ethics submissions, including document preparation, authority and committee communications, translation review, documentation tracking, safety reporting, training, and feasibility support. Requires a college/university degree or equivalent education, training and experience; prior ANVISA submission experience; clinical trial regulatory experience; fluent English and Portuguese; and MS Office proficiency.

Key requirements

• College/University degree or an equivalent combination of education, training and experience
• Required skills: Clinical trial regulatory submissions, Regulatory activities for clinical trials, Preparation of regulatory and ethics submission documents, Communication with regulatory authorities, Support for communication with ethics committees, project teams and vendors, Review of translations of essential clinical trial submission documents, Regulatory documentation tracking, Review of documents for investigational product release to sites, Safety reporting to authorities, Regulatory training delivery, Feasibility research and business development support, MS Office proficiency, Detail orientation, Planning and teamwork, Communication, Collaboration, Problem-solving
• Required languages: English, Portuguese

Opportunity details

• Workplace: Hybrid
• Posted: Nov 4, 2026
• Original advert language: English

Full vacancy

HealthRoleIQ regularly verifies this opportunity against the employer’s posting and highlights the details relevant to your match.

Employer’s role description

Job title: Regulatory Officer

Location: Belgrade, Serbia

Employment type: Full-time

Workplace type: Hybrid

Company Description

PSI is a leading Contract Research Organization with more than 25 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.

Your role:

Prepare clinical trial documents for Regulatory and Ethics submissions
Communicate with regulatory authorities and support communication with 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 to ANVISA in Brazil
Prior experience with regulatory activities for clinical trials
Full working proficiency in English and Portuguese, Spanish is a plus
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 offer:

Excellent and flexible working conditions
Extensive training and friendly, collegial team
Competitive salary and benefits package
Opportunities for personal and professional growth

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.