Head of Regulatory Affairs Israel

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

Qualifications:

• 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

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About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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