Regulatory Officer

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.