Regulatory Affairs Officer
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Job Location:
Tilburg - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
08-11-2025
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
Discover Impactful Work:
In this role you will collect write and maintain documents for regulatory submissions ensuring compliance with GMP company and pharmaceutical guidelines. You will prepare and submit CMC sections of registration dossiers and variations answer regulatory inquiries from partners and initiate and handle change control records having the responsibility for progress of the completed actions. Review the specifications and Batch Master Records will also be part of your role.
Experience
Proven experience in a similar role within the Pharmaceutical/BioTech industry for at least 3 years is required.
Knowledge Skills Abilities
- Passion for problem-solving attention to detail and strong organizational skills.
- Sound understanding of GMPs and Manufacturing.
- Proficiency in writing reviewing and preparing full dossiers and submissions per EU guidelines.
- Familiarity with European national and MRP/DCP submissions and FDA legislation.
- Knowledge of GMP EP and US pharmacopeia.
- Experience with eCTD software for submission preparation.
- Excellent planning and communication skills in English; Dutch is a plus.
Physical Requirements / Work Environment
You will enjoy a diverse work environment with significant freedom and flexible work hours. There is ample opportunity for career growth including project responsibilities where you will represent Regulatory Affairs as a core team member in new product development.
Required Experience:
Unclear Seniority
Key Skills
- Information Technology
- Consumer Durables
- Apps
- Facilities
- Gym
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
