Responsibilities:

• Plan, direct, and monitor regulatory affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce its goods and services.
• Dossier creation, submission and registration
• Life cycle management of regulatory files
• Ensure promotional material complies with regulatory guidelines
• Manage external vendors
• Support development of roles and work processes.
• Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvals.
• Monitor regulatory developments and advise management on the potential impact of regulations on our organization.
• Establish and maintain relationships with government agencies and other regulatory authorities.
• Represent us in matters before regulatory, legislative, or industry standards agencies so our interests are advanced.
• Prepare materials for legal counsel or external consultants.
• Create and compile of registration application documentation.
• Regulatory system, data entry and maintenance in/of regulatory systems.
• Collaborate with the Ministry of Health
• You will report to the Regional Regulatory Cluster Lead

• Registered Pharmacist
• Previous experience as appointed pharmacist in Israel
• 3+ years regulatory experience in the pharmaceutical industry
• Experience in matrix structures
• Collaborative with hands-on attitude
• Fluency in Hebrew and English