Senior Director of Regulatory Affairs and Non-Clinical JB-17

The Senior Director of Regulatory Affairs and Non-Clinical, is a managerial position responsible for management and overseeing the preparation, submission and interactions of regulatory submissions (CMC, non clinical and clinical) to health authorities, ensuring that all company products meet legal requirements. This position is also responsible for all toxicology studies required to support the clincial program and regulatory submissions. The role requires strong communication and project management skills to coordinate with internal teams and external stakeholders. He/She will report to the VP of Clinical Development and Regulatory Affairs.

Key responsibilities:

• Regulatory Strategy Development: Establish and execute regulatory strategies for products, ensuring all necessary applications are filed and compliance is maintained throughout the product lifecycle

· Manage and oversee the preparations, review and approval of materials (e.g. briefing package, DSUR, IB, IND etc) for regulatory submissions, interactions and meetings with Regulatory Authorities (e.g.FDA, EMA, National RA bodies), serve as the company primary contact with regional regulatory advisors

• Oversight of the activities related to the authoring and review process (between Protalix, advisors or collaborators) of regulatory documents (such as IB and DSUR), and any update of these documents
• Compliance Monitoring: Ensure all company products comply with current regulations, including labeling, packaging, and advertising standards
• Cross-Functional Collaboration: Work closely with other departments such as Manufacturing, Clinical, R&D, and Quality Assurance to align regulatory strategies with business objectives and product development
• Risk Management: Identify potential regulatory obstacles and develop strategies to mitigate risks associated with product development and marketing
• Training & Education: Provide guidance and training to internal teams on regulatory requirements and best practices
• Market Intelligence: Stay informed about changes in regulatory policies and guidelines, and assess their impact on the company’s products and processes
• Serves as a primary contact for regulatory product-related communications between Protalix and its Partners per product

· Establish and execute non-clinical strategies for products under development and ensure that the studies meet the regulatory requirements, and program strategy

Qualifications:

• Education: Master's or PhD in a scientific discipline, or an MD or DVM degree
• Experience: 5+ years of experience in regulatory affairs of innovative drugs within the pharmaceutical industry, with proven experience in managing regulatory submissions
• Knowledge: Strong understanding of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines
• Management Skills: Proven experience in direct management and leading cross-functional teams
• Experience in leading non-clinical studies - advantage
• Scientific knowledge in therapeutic drugs, recombinant proteins - advantage
• Experience with regulatory submissions for both drugs and biologics - advantage
• Communication Skills: Strong written and verbal communication skills, with the ability to present complex regulatory information to a diverse audience

Skills:

• Excellent written and verbal communication skills in English and Hebrew.
• Strong direct team management, project management and organizational skills.
• Ability to work under pressure and meet tight deadlines.
• Detail-oriented with strong analytical and problem-solving skills.
• Proficiency in regulatory information management systems.