Regulatory Associate

We are looking for a Regulatory Associate to join our team at our R&D center, Israel.

The Regulatory Associate will play a key role in improving and maintaining regulatory processes and workflows to support efficient and compliant operations.

Responsibilities include managing documentation, coordinating activities within the regulatory team and across departments, and tracking progress to ensure timely execution of regulatory deliverables.

The role requires strong organizational and communication skills, attention to detail, and the ability to collaborate effectively across functions, as well as strong proficiency in Excel-based tracking and related workflow tools.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Regulatory Project Management: Support the development, coordination, and maintenance of regulatory activities to ensure timely task execution. Collaborate with Quality, Clinical, Operations, and R&D teams to gather required information and ensure smooth execution of regulatory processes.
• Tracking Regulatory Activities:
• Maintain and update Excel-based trackers and other tools to capture timelines, milestones, and task status for regulatory projects.
• Monitor the status of regulatory changes, updates, and pending tasks, following up with responsible stakeholders to ensure timely completion and process adherence.
• Data Collection and Reporting: Compile and consolidate information from multiple sources to support reporting, metrics tracking, and overall visibility of regulatory activities.
• Operational Submission Support: Assist in preparing regulatory submissions from an operational perspective, including assembling documentation, verifying completeness, and coordinating logistics with the Regulatory Affairs team.
• Signature Coordination: Manage document routing and the collection of required signatures for regulatory approvals and controlled documentation, ensuring compliance with established procedures.
• Labeling Process Coordination: Coordinate and monitor labeling/labels activities, including artwork reviews and approvals, to ensure accuracy and compliance with regulatory and quality requirements.
• Process Documentation: Assist in maintaining and updating standard operating procedures (SOPs), templates, and process-related documentation to ensure consistency and transparency.
• RIM System Management: Work within the Regulatory Information Management (RIM) system to input, update, and track regulatory records, ensuring data integrity and alignment with current regulatory activities .
  
  

• Qualifications:
• Bachelor’s degree in Life Sciences, Business Administration, or related field
• Knowledge:

• 2 years of experience in regulatory affairs, operations coordination, or process management.
• Advanced proficiency in Microsoft Excel (formulas, pivot tables, conditional formatting) and familiarity with project management tools (e.g., Smartsheet, Monday.com).
• Strong interpersonal, organizational and communication skills.
• Ability to manage multiple tasks and prioritize effectively.
• Experience with document control systems or ERP tools is a plus.
  

• Proactive, reliable, and adaptable to changing priorities.
• Strong English language proficiency, both written and verbal.