Regulatory Affairs Professional

About the Role

This is a challenging and rewarding opportunity for an experienced Regulatory Affairs professional to join our team at CSL Behring.

We are seeking a highly skilled individual with a strong background in regulatory affairs, particularly in the pharmaceutical industry, to lead our regulatory activities in Israel.

The successful candidate will be responsible for planning, directing, and monitoring regulatory affairs activities to ensure compliance with relevant regulations and guidelines. This includes dossier creation, submission, and registration, as well as life cycle management of regulatory files.

Key Responsibilities

• Plan, direct, and monitor regulatory affairs activities to ensure compliance with relevant regulations and guidelines
• Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle
• Develop and implement strategies to ensure timely and compliant submissions to regulatory authorities
• Maintain relationships with government agencies and other regulatory authorities
• Represent the company in matters before regulatory, legislative, or industry standards agencies
• Prepare materials for legal counsel or external consultants
• Ensure promotional material complies with regulatory guidelines

Requirements

• Registered Pharmacist with 3+ years of experience in regulatory affairs in the pharmaceutical industry
• Previous experience as appointed pharmacist in Israel
• Strong knowledge of Israeli regulations and guidelines related to pharmaceuticals
• Excellent communication and interpersonal skills
• Fluency in Hebrew and English

What We Offer

• A competitive salary of $120,000 - $150,000 per year
• A comprehensive benefits package, including health insurance, retirement plan, and paid time off
• The opportunity to work with a dynamic and global biotechnology company
• A collaborative and supportive work environment

About Us

CSL Behring is a leading global biotechnology company dedicated to saving lives through innovation. We develop and deliver therapies that treat rare and serious diseases, including hemophilia and immune disorders. Our products improve the lives of thousands of patients worldwide, and we are committed to continuing this important work.