PSI CRO is hiring a

Submission Specialist / Regulatory Officer

Ra'anana, Israel
Full-Time

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

  • 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

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.

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