Regulatory Officer

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.