Regulatory Officer

at  PSI CRO

Company Description
PSI is a leading Contract Research Organization with more than 29 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.
Hybrid working arrangement in Bucharest, Romania

QUALIFICATIONS

• College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions, including submission in EU Clinical Trial Information System as per EU CT Regulation
• Full working proficiency in English; French, Spanish and/or Portuguese are 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 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

• 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