Regulatory Affairs Manager

Company Description

ELGAN Pharma is a neonatology-focused biotechnology company dedicated to developing safe and tailored therapies to address medical problems and developmental difficulties common in babies born prematurely, specifically extremely low gestational age newborns. As the number one cause of newborn deaths, premature birth accentuates the need to improve healthcare and quality of life in this population. Our mission is to improve health outcomes for ELGANs by conducting meaningful scientific research with the hope of making a demonstrable difference in the lives of these vulnerable infants.

Role Description

The Regulatory Affairs Manager will be responsible for leading and managing regulatory efforts from planning to execution. The role will require coordination and management of product submissions, regulatory compliance, and implementation of quality systems. This is a full-time on-site role, located in Ramat Gan, Israel, and may require occasional travel.

Qualifications

• Regulatory Compliance and Regulatory Requirements knowledge and experience
• Expertise in Regulatory Affairs and experience with regulatory submissions including NDA, IND, BLA, and CTA
• Knowledge and experience in CMC Regulatory Affairs is a plus
• Knowledge and experience in medical writing is a plus
• Bachelor's degree or higher in chemistry, biology, pharmacy, or a related field; Master's degree preferred
• Strong communication, analytical, and leadership skills
• Ability to lead a project team and manage multiple priorities
• Organizational skills and attention to detail