Regulatory Affairs Specialist

Regulatory Affairs Specialist

Tired of working on just one small part of the regulatory process?

At Interchemie, it’s different. As a Regulatory Affairs Specialist, you manage regulatory dossiers from A to Z and are involved in the entire lifecycle of a product, across international markets.

Unlike many Regulatory Affairs positions in the Netherlands, this role does not require Dutch. The entire RA team works in English.

Your Challenge

As a Regulatory Affairs Specialist, you oversee the regulatory process throughout the entire lifecycle of a product. You prepare and submit new registrations, maintain dossiers, and manage variations and renewals for your own portfolio of countries.

Your work is closely connected to the rest of the organization. You collaborate daily with colleagues from QA, QC, logistics and sales to make sure products can be registered, released and shipped without delays. Regulatory Affairs sits at the center of this process: if the documentation is not correct or complete, products cannot move forward.

At the moment the team is working on several large projects, including the transfer of registrations to a new manufacturing site and the integration of dossiers from newly acquired companies. You will step into an environment where regulatory work requires ownership, problem solving and collaboration across teams.

This role fits someone who already knows what working in a regulated environment asks in practice: accuracy, documentation and consistency. Small details can have large consequences for registrations, so attention to detail and a structured way of working are essential. With one to three years of experience in the field, you know the work from practice and you are ready to take ownership of your own portfolio.

At the same time, the role offers variety and international exposure. You will work with dossiers for multiple regions and interact with agents and authorities across different markets, while gaining a complete view of the regulatory lifecycle of veterinary medicines.

Main responsibilities

• Prepare, compile and submit regulatory dossiers for new product registrations across international markets
• Manage the full lifecycle of regulatory dossiers, including variations, renewals and updates
• Take ownership of a portfolio of countries and ensure registrations remain compliant and up to date
• Maintain and organize regulatory documentation according to country-specific regulatory requirements
• Communicate with regulatory authorities, agents and partners regarding submissions, questions and approvals
• Monitor regulatory developments and ensure product documentation remains aligned with regulatory requirements
• Collaborate closely with QA, QC, logistics and sales to ensure products can be registered, released and supplied to the market
• Support the transfer and maintenance of registrations when manufacturing sites or product documentation change
• Contribute to improving regulatory processes, documentation and internal workflows

About Interchemie

Interchemie develops, produces and distributes veterinary medicines, nutritional products and disinfectants for international markets. The company manages a portfolio of more than 100 products and operates in over 120 countries worldwide.

From its headquarters in Waalre, the Netherlands, and production sites in the Netherlands, Estonia and Lithuania, Interchemie works within a highly regulated environment and manufactures according to GMP and GMP+ standards.

Interchemie is an international and multicultural organisation, with colleagues from many different backgrounds working together across locations and disciplines. The organisation is growing and changing, with clear responsibilities, short communication lines and close collaboration between teams. For people who like working in an international setting, taking ownership and seeing the direct result of their work, this creates a concrete and professional working environment.

We Offer

• A Regulatory Affairs role where you are involved in the full product lifecycle instead of just one part of the process
• Responsibility for your own portfolio of countries and regulatory dossiers
• A salary with a maximum of € 4.000, - gross per month, depending on knowledge and experience, and good secondary employment conditions
• An international working environment with registrations across many different markets
• Close collaboration with QA, QC, logistics and sales within a growing organization
• The opportunity to develop your expertise in Regulatory Affairs while working on a broad range of products and markets
• A full-time position at our office in Waalre

We Ask

• A completed Master’s degree in Life Sciences
• 1 to 3 years of relevant work experience in Regulatory Affairs or a regulated pharmaceutical or life sciences environment
• Currently living within one hour of Waalre
• Full-time availability, working on-site at our office in Waalre
• Accuracy and a structured way of working with regulatory documentation
• The ability to manage multiple dossiers and regulatory requirements simultaneously
• Strong communication skills and the ability to collaborate with colleagues and external partners
• Fluency in English (Dutch is not required)
• Speaking Russian is a strong plus, not a requirement

Apply

Are you the Regulatory Affairs Specialist we are looking for? Do you recognize yourself in this profile and do you currently live within an hour of Waalre? Click the button to apply.

You will receive a response within a few working days.

Do you have questions or would you like to discuss the role first? Send me an email to lynn@interchemie.com

Soort dienstverband: Fulltime

Salaris: Tot €4.000,00 per maand

Arbeidsvoorwaarden:

• Pensioen
• Reiskostenvergoeding

Werklocatie: Fysiek