Regulatory Officer at PSI CRO

São Paulo, São Paulo, Brazil -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

0.0

Posted On

18 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory submissions, Ethics submissions, Clinical trials, Regulatory affairs, Safety reporting, Project management, Regulatory training, Feasibility research, Business development, MS Office, English, Portuguese, Spanish, Communication, Collaboration, Problem-solving

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The Regulatory Officer will prepare and manage clinical trial documents for regulatory and ethics submissions while coordinating with authorities and project teams. They will also oversee safety reporting, provide regulatory training, and support business development and feasibility research.