Senior Regulatory Officer - Clinical Trials

About the role

PSI CRO, a global company founded in 1995 with more than 3,000 people working on the front line of medical science, is looking for a Senior Regulatory Officer in Prague. You will join the team of experts in regulatory and ethics submissions of clinical studies, focusing on helping start research projects for novel medicinal products. The role is hybrid and offers a competitive salary and benefits package.

Key responsibilities

• Prepare and oversee the preparation of clinical trial submissions.
• Act as Regulatory Lead in complex clinical trials and programs, coordinating CTIS submissions and sharing responsibility for developing global and country-level submission strategies.
• Discuss submission strategy with sponsors and identify regulatory risks, working on mitigation plans.
• Keep approaches and regulatory processes consistent across multiple trials in a program.
• Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory matters.
• Review translations of essential documents, track the regulatory documentation flow and review documents to approve their release to sites.
• Manage safety reporting to authorities and 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.
• At least 5 years of experience with clinical trial submissions in the Czech Republic (Slovakia experience is an advantage).
• Extensive experience with the Clinical Trial Information System (CTIS).
• Full working proficiency in Czech (or Slovak) and English.
• Detail-oriented, able to learn, plan and work in a dynamic team, with communication, collaboration and problem-solving skills.

Required skills

• Proficiency in MS Office applications.
• Extensive use of CTIS.