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
Qualifications
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
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.
... You will: Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import ... training and experience Clinical trial industry experience Prior experience with clinical trial submissions in Kazakhstan Full working proficiency ...
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