Head Of Regulatory Affairs Israel

Head of Regulatory Affairs Israel

Head of Regulatory Affairs Israel

Apply locations : APAC, IL, Ra’anana, CSL Behring

Time type : Full time

Posted on : Posted Yesterday

Job requisition id : R-247644

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 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

Qualifications :

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