Country Approval Specialist / Regulatory Officer

2/8/2026

The specialist will prepare clinical trial submission dossiers for Regulatory and Ethics Authorities and manage communication with these bodies, project teams, and vendors regarding regulatory matters. Responsibilities also include reviewing essential document translations, tracking regulatory documentation flow, managing safety reporting, and delivering regulatory training.

Working Hours

40 hours/week

Company Size

1,001-5,000 employees

Language

English

Visa Sponsorship

About The Company

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

About the Role

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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 and Ethics Authorities
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.

Key Skills

Regulatory SubmissionsEthics SubmissionsClinical Trial DossiersRegulatory Authorities CommunicationEthics Committees CommunicationTranslation ReviewDocumentation Flow TrackingSafety ReportingRegulatory TrainingFeasibility ResearchBusiness DevelopmentDetail-orientedCommunicationCollaborationProblem-solving