Compliance Specialist

The Regulatory Affairs Specialist plays a vital role in 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 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

At CSL Behring, we value diversity and inclusion, and strive to reflect the world around us. Our team members enjoy a supportive and inclusive environment where they can grow professionally and personally.

We prioritize our employees' well-being and offer benefits that support their health and happiness.

$85,000 - $110,000 per annum, depending on location and experience.