Regulatory Support Specialist, Boxmeer, Noord-Brabant

The Company
The company is a global pharmaceutical company originally from Germany. They have multiple locations in the Netherlands, one focusing on animal health.

Role Description
The client is looking for a detail-oriented and proactive Regulatory Support Specialist to join their regulatory affairs team. In this role, you will provide essential administrative and coordination support for regulatory processes, contributing to the successful maintenance of product compliance and documentation. You’ll play a key role in tracking regulatory activities, managing submissions, and supporting local and international regulatory requirements. 

Responsibilities

• Maintaining and updating internal regulatory tracking systems and databases to ensure accuracy and compliance.
• Preparing and supporting the submission of regulatory documentation including renewals, PSURs (Periodic Safety Update Reports), and other local filings.
• Assisting in the management of product artwork and labeling in line with regulatory standards.
• Performing minor translations of regulatory documents to support submission and review processes.
• Organizing and maintaining local regulatory files, ensuring they are up-to-date and audit-ready.
• Providing administrative support for regulatory projects and collaborating with cross-functional teams.
• Contributing to additional regulatory activities and tasks as required by the department. 

Requirements

• Proven experience in a regulatory or administrative support role, preferably within the pharmaceutical or animal health industry.
• Strong organizational and coordination skills with attention to detail.
• Ability to work independently with minimal supervision.
• Proficient in the use of databases and Microsoft Office applications.
• Excellent written and verbal communication skills in both Dutch and English.
• Familiarity with regulatory documentation such as PSURs, renewals, and product artwork is a plus.
• A proactive mindset with the ability to manage multiple tasks and priorities. 

Other information  
Apply to our vacancy for more information. Looking forward to getting in touch!   

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