Sobre

• 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
• We are looking for a Regulatory Officer to join our team in regulatory submissions of clinical studies in Mexico (and Latin America). 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
• Qualifications
• 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
• Additional Information
• Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.