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.

We are looking for a Regulatory Officer to join our team in regulatory and ethics submissions of clinical studies in Mexico. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

Only CVs in English will be accepted

Your role:

Prepare clinical trial submission dossiers for Regulatory Authorities
Prepare country level patient facing documents
Communicate with regulatory authorities, 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 in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experience
Prior experience with clinical trial submissions
Full working proficiency in English
Proficiency in MS Office applications
Detail-oriented
Ability to learn, plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

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