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Regulatory Affairs in Clinical Trials at PSI CRO

Ciudad de México, , Mexico -

Full Time

Start Date

Immediate

Expiry Date

25 Dec, 25

Salary

0.0

Posted On

26 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, Clinical Trials, Communication, Collaboration, Problem-Solving, Detail-Oriented, MS Office, Safety Reporting, Training, Feasibility Research

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

Prepare clinical trial submission dossiers for regulatory authorities and manage safety reporting to authorities. Communicate with regulatory authorities and project teams on regulatory-related matters.