Regulatory Officer

About the role

PSI, a Contract Research Organization with more than 30 years in the industry, is hiring a Regulatory Officer for its Regulatory Affairs department in Belgrade. The role sits within the team handling regulatory and ethics submissions of clinical studies, focusing on helping start research projects for novel medicinal products. It is an office-based position.

Key responsibilities

• Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export licence applications
• Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory matters
• Review translations of documents needed for clinical trial submission
• Track the regulatory project documentation flow
• Review documents to authorise the release of intellectual property to sites
• Manage safety reporting to authorities
• Deliver regulatory training to project teams
• Assist with feasibility research and business development requests

Required profile

• College or university degree, or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions
• Full working proficiency in English and Serbian
• Detail-oriented, able to learn, plan and work in a dynamic team
• Good communication, collaboration and problem-solving skills