Non-Clinical and Clinical Regulatory Affairs 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 and Clinical RA Lead.

The Non-Clinical and Clinical RA Lead is responsible for supporting R&D in its non-clinical planning efforts, planning and managing the Toxicology studies as well as supporting clinical 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

1. Non-Clinical Regulatory leader

o Ensure regulatory compliance of non-clinical studies planned and performed by R&D

o Plan and execute toxicological studies to support regulatory submissions and product development

o Review and ensure compliance with Good Laboratory Practices (GLP) and relevant guidelines for non-clinical research

o Collaborate with external vendors, CROs, and academic partners to ensure the timely and quality completion of non-clinical studies, including liaising with Legal and Finance

2. Clinical regulatory Leader

o Ensure regulatory submission compliance of clinical studies planned and performed by Clinical Team

o Coordinate with cross-functional teams to compile and submit high-quality, regulatory-complied, clinical section documents within required timelines.

3. Regulatory Affairs

o Maintain up-to-date knowledge of FDA/EU/ICH guidance, submission processes and regulatory pathways

o Ensure compliance with applicable regulations (FDA, EMA, ICH, etc.) and industry standards

o Support any regulatory-related submissions activity, as needed

o Lead the preparation, writing, and submission of non-clinical regulatory documentation required for pre-INDs, Scientific Advice, INDs, CTAs, NDAs, BLAs, MAAs, and amendments

o Serve as the regulatory subject matter expert in cross-functional project teams

Qualifications

• Education: Master's or PhD in a scientific discipline, or an MD or DVM degree

• Experience: 5+ years of experience in regulatory affairs/ non clinical safety of innovative drugs within the pharmaceutical industry

• Knowledge: 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

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