The Company
Our client is a leading global company in the veterinary pharmaceutical industry, dedicated to improving animal health. With more than 133 years of exitance, they made  a big impact in animal health. Are you ready to make an impact too? 

Role Description

As an Regulatory Affairs Specialist, you will be part of the GRA Biologicals team, working to support the licensing and management of vaccines for swine and aquatic animals. You will work closely with internal teams and external regulatory agencies to manage product registrations and ensure that all vaccines meet regulatory standards in countries outside the EU.

Responsibilities

• Act as the main point of contact for local regulatory representatives (CORAs) and assist with communication between product managers and CORAs.

• Build and maintain strong relationships with internal teams (Product Managers, Operations, Pharmacovigilance) and external contacts, including regulatory agencies and third-party representatives.

• Coordinate and submit the necessary documents, including dossiers and variation packages, to obtain and maintain marketing authorizations for products.

• Ensure all regulatory documents are prepared on time and handle translation updates for authorized products.

• Prepare and manage responses to regulatory questions during licensing procedures to ensure timely and high-quality submissions.

• Track changes in regulatory requirements and communicate these to relevant teams to ensure compliance.

• Assist with internal projects related to regulatory databases and document management to improve efficiency.

Requirements

• A Bachelor’s degree in Veterinary Science, (Bio) Chemistry, Biology, Biomedical Science, or a related field, or relevant experience in regulatory affairs in the veterinary or pharmaceutical industry.

• Strong English skills, both written and spoken, with clear communication and attention to detail.

• Ability to work effectively in an international, multicultural environment.

• Basic knowledge of country-specific licensing requirements and product development processes, especially for veterinary biologicals.

• Familiarity with information systems and project management tools.

Other Information

This role offers the chance to work in an international team and contribute to the development of innovative animal health products. The position is based at the Boxmeer facility, a modern site that supports career growth and development. Apply to be part of the change!

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