רגולטור פארמה Regulatory officer

Role Description

This is a part-time (50%) hybrid position for a Regulatory Officer based in Haifa, with flexibility for occasional remote work. The role supports a multi-institutional program focused on pre-clinical and clinical research in gene therapy, conducted at the Technion, the University of Haifa, Rambam Health Care Campus, and additional collaborating institutes and companies.

The Regulatory Officer will be responsible for preparing, reviewing, and managing regulatory documentation; ensuring adherence to local and international regulatory requirements; and coordinating regulatory submissions. The role includes staying current with evolving regulatory frameworks, liaising with relevant regulatory authorities, and supporting cross-functional teams in obtaining approvals for advanced therapeutic products.

Mandatory

• Proven experience working with major regulatory agencies (e.g., FDA, EMA)

Highly Preferred

• Demonstrated experience with advanced therapy medicinal products (ATMPs), including gene or cell therapy
• Experience with regulatory pathways for rare diseases and orphan drugs

Additional Requirements

• Strong proficiency in regulatory documentation and regulatory submissions
• Deep understanding of regulatory compliance, requirements, and standards
• Excellent analytical, organizational, and detail-oriented skills
• Ability to work collaboratively across multidisciplinary teams
• Familiarity with pharmaceutical and biotechnology regulatory frameworks
• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related discipline (advanced degree advantageous)
• Fluency in English