Regulatory Officer

About the role

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 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 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

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Psicro? Share your experience