Regulatory Affairs Officer, Boxmeer, Noord-Brabant

The Company
Our client is a leader in global healthcare with a strong presence in the Netherlands, working on both human and animal health innovations.

About the Role
The role centers on licensing activities for both new and existing products, with a strong emphasis on regulatory submissions and compliance with updated veterinary regulations. You’ll be part of a project team responsible for updating product information across the EU and supporting broader licensing efforts.

Key Responsibilities
- Serve as the main contact for regulatory authorities and internal teams on licensing matters
- Manage dossier submissions, variation packages, and responses to regulatory questions
- Lead standard licensing procedures and support complex ones when needed
- Coordinate translation updates and maintain accurate records in regulatory systems
- Monitor regulatory changes and contribute to submission planning and strategy
- Participate in cross-functional teams for product registration and maintenance
- Support internal projects related to regulatory platforms and provide guidance to junior staff

Requirements
- University degree or HBO-level education in Veterinary Science, Biology, Biochemistry, or a related field
- 3–5 years of experience in regulatory affairs, ideally within biologicals
- Familiarity with product development and maintenance in the pharmaceutical or veterinary sector
- Strong written and verbal communication skills in English
- Skilled in identifying and resolving complex regulatory issues
- Proficient in regulatory systems and able to train others

Other Information
Possible extension after the end of the contract

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