Pharmaceutical Regulatory Expert

The Regulatory Affairs Specialist is responsible for ensuring the company's compliance with regulatory requirements. This includes planning, directing, and monitoring regulatory affairs activities to obtain necessary permits, licenses, certificates, authorizations, and approvals.

• Dossier Creation and Submission: The Regulatory Affairs Specialist prepares and submits high-quality dossiers to support product approvals and licensing by collaborating with cross-functional teams and identifying regulatory gaps.
• Regulatory File Management: The specialist oversees the life cycle management of regulatory files, including maintenance, updates, and archiving, to ensure compliance with relevant regulations and guidelines.
• Promotional Material Compliance: The Regulatory Affairs Specialist ensures promotional materials comply with regulatory guidelines to maintain accurate and truthful marketing practices by reviewing and approving all marketing materials.
• Vendor Management: The specialist manages relationships with external vendors to secure essential services for regulatory compliance, including conducting regular vendor audits and performance assessments.
• Process Development: The Regulatory Affairs Specialist supports the development of roles and work processes to ensure efficient regulatory operations by identifying areas for improvement and implementing process changes.
• Project Planning: The specialist collaborates with teams to plan, cost estimate, and schedule projects related to regulatory compliance, including developing project plans and tracking project progress.
• Regulatory Monitoring: The Regulatory Affairs Specialist stays up-to-date on regulatory developments and advises management on potential impacts on our organization by attending industry conferences and participating in regulatory forums.
• Government Relations: The specialist establishes and maintains relationships with government agencies and other regulatory authorities to advance our interests by building relationships with key stakeholders.
• Representation: The Regulatory Affairs Specialist represents the company in matters before regulatory, legislative, or industry standards agencies by communicating with regulatory officials and advocating for the company's interests.
• Documentation Preparation: The specialist prepares materials for legal counsel or external consultants to support regulatory submissions by gathering and compiling relevant documentation.
• System Maintenance: The Regulatory Affairs Specialist performs data entry and maintenance in regulatory systems to ensure accuracy and compliance by updating system records and ensuring data integrity.

• Professional Qualification: Registered Pharmacist
• Experience: 3+ years regulatory experience in the pharmaceutical industry, previous experience as appointed pharmacist in Israel
• Skill Set: Collaborative with hands-on attitude, fluency in Hebrew and English, experience in matrix structures

CSL Behring is a leading global biotechnology company with a dynamic portfolio of life-saving medicines and vaccines. We value diversity and inclusion, and strive to reflect the world around us.

At CSL Behring, we prioritize our employees' well-being and offer benefits that support their health and happiness.

The estimated salary range is $85,000 - $110,000 per annum, depending on location and experience.