Country Approval Specialist / Regulatory Officer
Posted about 22 hours ago
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 your professional career.
Office-based role in Ra'anana , Israel
You will:
Prepare clinical trial submission dossiers for Regulatory Authorities and Ethics Committees
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 of at least one year with clinical trial submissions in Israel within the CRO or Pharmaceutical industries
Full working proficiency in English and Hebrew
Proficiency in MS Office applications and `Matarot’ software
Detail-oriented
Ability to learn, plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
*Please send your CV in English
Additional Information
We offer:
- Excellent working conditions
- Extensive training and friendly team
- Competitive salary and benefits package
- Opportunities for personal and professional growth
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Other open roles at PSI CRO(6)
PSI is a leading full-service global CRO (Contract Research Organization). Predictable patient enrollment across multiple therapeutic areas.
Key team members

Alex Goñi
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