Regulatory Affairs Officer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job 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.