Regulatory Officer / Senior Regulatory Officer at PSI CRO

Tbilisi, , Georgia -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

0.0

Posted On

17 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical trial submissions, Regulatory affairs, Ethics submissions, Regulatory documentation, Safety reporting, Project management, Time management, Communication, Collaboration, Problem-solving, Regulatory guidelines, Document review, Feasibility research, Business development

Industry

Pharmaceutical Manufacturing

Description

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them. 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 developing your professional career. Full-time, office-based in Tbilisi, Georgia Your role: Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, 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 Qualifications College/University degree or an equivalent combination of education, training and experience Life Science degree is a plus Prior experience with clinical trial submissions and/or marketing authorizations/registration of medicinal products Clinical trial industry experience is a plus Full working proficiency in English and Georgian Strong organizational skills with the ability to manage multiple projects simultaneously Excellent time management skills and ability to meet tight deadlines Ability to interpret and apply complex regulatory guidelines Communication, collaboration, and problem-solving skills Additional Information 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. Our Regulatory team is highly responsive, supportive, and flexible, always striving to deliver a standout service experience for both internal and external customers. Please submit your CV in English.

Responsibilities

The Regulatory Officer will prepare clinical trial submission dossiers for regulatory and ethics authorities and manage the regulatory project documentation flow. They will also communicate with project teams and vendors while ensuring safety reporting and regulatory training are delivered effectively.