Regulatory Officer

PSI CRO

2d

About The Position

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the research projects of novel medicinal products, while taking a step further in your professional career.

Requirements

• College/University degree or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions in North America.
• Full working proficiency in English and French, native French speaker competency required, US Spanish speaker competency beneficial.
• Proficiency in MS Office applications
• Detail-oriented
• Ability to learn, plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

Responsibilities

• Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, with a specific focus on Canadian and US regulatory submissions, 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree