Submission Specialist / Regulatory Officer

Company Description

PSI is a leading Contract Research Organization with more than 25 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
  
  

• 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