Regulatory Affairs Coordinator

**Functieomschrijving**:
You will be responsible to prepare and maintain European marketing authorisations of veterinary medicines (generic and non-generic). You will report directly to the head of the Regulatory, Research and Development department.

**Your responsibilities include**:

- Ensuring regulatory compliance of veterinary medicine product information.
- Primary contact for responding to administrative questions from regulatory authorities.
- Key function in maintaining regular contact with our distributors and where necessary, local partners, for the follow-up of regulatory issues.
- Liaising with technical manager concerning scientific information of our product portfolio.
- Updating and maintaining regulatory affairs registration dossiers.
- Developing regulatory expertise in the current veterinary medicines legislation.
- Ensure regulatory compliance of our products by working closely with the Quality Assurance department (through our QMS).

**Profiel**:

- Scientific bachelor or master degree (pharmacy, chemistry, biomedical sciences or veterinary medicines are preferred) or equivalent experience.
- Minimum 1 year of experience in regulatory aspects, in the (veterinary or human) pharmaceutical industry.
- Proficient in English and Dutch, good knowledge of French is an asset but not a requirement.
- Proactive and dynamic, able to take initiative and work autonomously.
- Manage multiple projects and enquiries in an efficient and structured manner.
- Excellent attention to detail and accuracy.
- Good administrative skills, flexible and able to meet critical deadlines
- Team driven, empathic and communicative.
- Eager to learn and develop new expertise.

**Aanbod**:

- A responsible and varied position in a financially stable, growing and internationally oriented company
- A pleasant and dynamic working environment
- Focus on development and training