Regulatory Affairs Specialist

A leading pharmaceutical company is looking for a Regulatory Affairs Specialist to join its Registration and Regulatory Affairs department and support the ongoing maintenance of pharmaceutical product registrations.

The company operates in a regulated pharmaceutical environment and works closely with health authorities, manufacturers, suppliers, and internal teams. This is a detail-oriented regulatory role focused on maintaining product registrations, managing regulatory changes, updating labeling materials, and ensuring documentation remains accurate and compliant.

Responsibilities

• Manage regulatory variations and follow their approval and implementation.
• Handle registration renewals and maintain product registration files.
• Update and submit physician and patient leaflets, including version comparison and wording control.
• Manage packaging, labeling, and artwork updates and verify alignment with approved documentation.
• Work with CTD files and supporting regulatory documentation.
• Communicate with the Israeli Ministry of Health, manufacturers, and suppliers in Israel and abroad.
• Track regulatory tasks, timelines, document versions, and approval status.
• Coordinate with internal teams to ensure timely implementation of approved regulatory changes.
• Maintain accurate and organized regulatory documentation across multiple products.

Required Qualifications

• Academic degree in Life Sciences, including Pharmacy, Biology, Chemistry, or another relevant field – must.
• At least 2 years of experience in Registration / Regulatory Affairs in the pharmaceutical industry – must.
• Hands-on experience with variations, renewals, leaflets, and/or packaging materials – must.
• Very high level of English, with strong professional reading and writing skills – must.
• Ability to work independently with a high level of accuracy, organization, and attention to detail.
• Ability to manage multiple tasks and priorities simultaneously.
• Experience working with the Israeli Ministry of Health and/or additional regulatory authorities.

Job No.: 500515