Non-Clinical Regulatory Lead JB-30

At Protalix, our focus is to develop, produce and commercialize potentially better

therapies for a variety of illnesses through cutting-edge research and development and

our proprietary plant cell-based protein expression platform.

If you wish to be a part of our success and join a dynamic and professional team that

allows personal and professional growth, we are looking for you.

We’re looking for a Non-Clinical Regulatory Lead.

The Non-Clinical Regulatory Lead is responsible for supporting non-clinical planning and executing efforts throughout product life cycle, including early development and toxicology studies as well as supporting regulatory submissions. The individual will work collaboratively with cross-functional teams, including R&D, bioanalytical, clinical and quality as well as liaise with CROs and relevant regulatory consultants. He/She will report to the Head of Regulatory Affairs.

Key Responsibilities

• Support early development non-clinical efforts by R&D while ensuring regulatory submissions’ compliance
• Plan and execute toxicological studies in compliance with Good Laboratory Practices (GLP) and relevant guidelines for non-clinical research
• Collaborate with external vendors, CROs, and academic partners to ensure the timely and quality completion of non-clinical studies
• Maintain up-to-date knowledge of FDA/EU/ICH guidance, submission processes and regulatory pathways
• Lead the preparation, writing, and submission of non-clinical regulatory documentation required for pre-INDs, Scientific Advice, INDs, CTAs, NDAs, BLAs, MAAs, and amendments
• Serve as the non-clinical regulatory subject matter expert in cross-functional project teams
• Support any regulatory-related submissions activity, as needed

Qualifications

• Experience in Toxicology/ non clinical safety of innovative drugs within the pharmaceutical industry - Must
• Master's or PhD in a scientific discipline, or an MD or DVM degree
• Understanding of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines.
• Previous experience with vendors’ management and outsourcing
• Previous experience working with cross-functional teams and regulatory consultants
• Experience with regulatory submissions for both drugs and biologics – Advantage
• Experience in Clinical-related submissions - Advantage

Skills and Competencies

• Excellent written and verbal communication skills in English and Hebrew.
• Strong project management and organizational skills.
• Ability to manage multiple projects simultaneously and meet tight deadlines