Head of Regulatory Affairs - Israel

December 10

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CSL

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Complex biologicals • vaccines • plasma and plasma derived therapeutics • biotechnology

10,000+ employees

Founded 1916

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 $111M Post-IPO Equity on 2004-02

Description

• Plan, direct, and monitor regulatory affairs activities. • 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 necessary permits and approvals. • Monitor regulatory developments and advise management. • Establish and maintain relationships with government agencies. • Represent us in matters before regulatory agencies. • Prepare materials for legal counsel or external consultants. • Create and compile registration application documentation. • Regulatory system, data entry and maintenance.

Requirements

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

Benefits

• We encourage you to make your well-being a priority. • It’s important and so are you.