Regulatory Officer (Clinical Trial Submissions)
Summary
Prepare and submit clinical trial dossiers to Kazakh authorities, manage licensing, and coordinate with ethics committees and project teams.
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 in Kazakhstan, while taking a step further in your professional career.
Office-based in Almaty
You will:
- 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
- College/University degree or an equivalent combination of education, training and experience
- Clinical trial industry experience
- Prior experience with clinical trial submissions in Kazakhstan
- Full working proficiency in English and Kazakh
- Proficiency in MS Office applications
- Detail-oriented
- Ability to learn, plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
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.