Regulatory Officer Senior Regulatory Officer

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.

Remote Work :

No

Employment Type :

Full-time