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Non-Clinical / Toxicology Regulatory Affairs Lead

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

Research Assistant - HPLC and Mass Spectrometry Laboratory

Job Description - Research Assistant - HPLC and Mass Spectrometry Laboratory

Protalix BioTherapeutics is an innovative biopharmaceutical company specializing in the production of recombinant protein drugs using plant cell technology. Protalix is seeking a dedicated research assistant to join our analytical R&D team. This role primarily involves conducting LC sample analysis and assay development, focusing on protein-related substances, process impurity identification, quantification, and assay qualification.

Key Responsibilities:
•    Perform analytical analysis of proteins and small molecules using various chromatographic techniques, including HPLC and LC-MS
•    Contribute to analytical method development initiatives
•    Draft SOPs and method development reports
•    Analyze samples from batch release and stability studies

Key Requirements:
•    M.Sc/B.Sc. degree in Biological Sciences, Chemical Engineering, Biotechnology Engineering, or Chemistry.
•    Hands-on experience in industry and/or academic settings.
•    Experience in analytical protein separation and characterization using LC and LC-MS – an advantage
•    Familiarity with HPLC systems (e.g., Thermo, Waters) – an advantage.
•    Proficiency in chromatographic software such as Chromeleon and Empower – an advantage.
•    Self-motivated with excellent communication and collaboration skills
 

Head of Regulatory CMC

Job Description - Head of Regulatory CMC

The Head of regulatory CMC is responsible for the overall regulatory-related CMC activities throughout the product life-cycle management, including: early development stages, phase 1-3 clinical development, BLA and Post Marketing requirements and activities.
The Head of CMC will work collaboratively with cross-functional teams, including R&D, analytical, QC/QA, clinical and supply chain as well as liaise with CMOs, regulatory consultants and company’s global partners. 
The Head of regulatory CMC will report to the Head of Regulatory Affairs. The position requires presence at the Carmiel office at least 3 times a week

Key Responsibilities:
•    Ensure phase-appropriate CMC regulatory compliance 
•    Lead the preparation and writing of CMC sections in FDA/EMA/ROW regulatory submissions
•    Writing of CMC-related regulatory documents
•    Oversee the activities with cross-functional teams to compile and submit high-quality dossiers within required timelines
•    Oversee the CMC-related responses to Health Authorities
•    Serve as the regulatory CMC- subject matter expert in cross-functional project meetings as well as in meetings with Health Authorities 
•    Maintain up-to-date knowledge of FDA/EU/ICH CMC-related guidance
•    Responsible to lead and guide CMC staff, including the development of a CMC-related training program
•    Liaising with CMC regulatory consultants 
•    Support Regulatory submission and activities as needed

Qualifications:
•    Education: Master's or PhD in a relevant scientific discipline,
•    Experience: 10+ years of experience in CMC regulatory affairs of innovative drugs within the pharmaceutical industry, including FDA/EMA submissions
•    Knowledge: Understanding of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines
•    Experience with regulatory submissions for biologics (Must) and Drugs
•    Previous experience with leading regulatory CMC projects

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
•    Leadership and  matrix management capabilities
 

Bioanalytical Laboratory Research Assistant

Job Description - Bioanalytical Laboratory Research Assistant

The bioanalytical laboratory is responsible for analyzing samples from animals and humans participating in Protalix's preclinical and clinical trials. The purpose of the analyzes is to evaluate the safety and effectiveness of the drugs developed by Protalix, using bioanalytical methods that meet regulatory requirements. Most laboratory methods are based on immunoassays such as ELISA and enzyme activity tests unique to each drug. The work includes involvement in method development, validation and analytical testing, while under control and documenting.
As part of the work, you gain experience working under GLP conditions and are exposed to the world of drug development, clinical trials and regulation.

Professional background:
• M.Sc master's degree in biology/biochemistry/pharmacology/immunology (master's degree including research work/thesis) or B.Sc bachelor's degree with work experience in the field.
• Experience in laboratory methods such as: ELISA, western-blot, PCR

skills:
• Ability to speak and write well in Hebrew and English
• Ability to work independently: experiment planning, calculations, writing reports, etc.
• Ability to work against deadlines and sometimes under pressure in order to meet the deadlines
• Pay attention to details
• Diligence, responsibility, commitment to tasks and the team and desire to work