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Vacature

Regulatory Affairs Specialist

You know what it takes to get a medicine right. In Regulatory Affairs at Interchemie, you take it one step further: you make sure it reaches the animals that need it.

Your countries, your dossiers, from first registration to renewal. Every approval you get opens a market and gets veterinary medicines to animals that need them.

You do this in a team that works entirely in English. Dutch is not required.

Informatie

Afdeling

Regulatory Affairs

Salaris

€3784 -

€5297

Locatie

Waalre

Uren

40 -

40u

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Wat ga je doen?

Je nieuwe uitdaging

As a Regulatory Affairs Specialist, you are responsible for your own countries. You know which renewals are coming, which registrations are running and where the site transfer stands. That transfer is the main project in the department right now: every registration has to move to our new manufacturing site in time.

A typical day starts with questions from customers, agents and colleagues. Then you work through your priorities: a variation, a question from an authority, a dossier that needs to go out. A customer who doesn't answer email gets a call or a WhatsApp.

Regulation is more than documentation. You learn the medicine itself: the formulation, the target species, the withdrawal period. And the rules keep moving. Countries outside the EU are moving towards EU standards, and a label approved today can meet a new rule tomorrow. You find out what changed, get confirmation on how to proceed and keep the product on the market. We are also bringing AI into our work, already for translations and soon for documents.

You don't start with a full portfolio. Your first days are about the systems: our database, the general file and the Trello board where we plan the work. Then you start with one country. A mentor guides you, first with small tasks, then larger ones, until you put together a full dossier yourself. One country can be months of work. Once it is under control, you take on a second and a third, at the pace you are ready for.

This role fits someone who wants to understand why a requirement exists and checks every dossier on its own merits.

Every approval opens a market. From that moment, our veterinary medicines reach animals in countries that need them.

Impact

Belangrijkste verantwoordelijkheden

  • Your own countries. You are responsible for the registrations in your countries: new registrations, renewals, variations and labels.
  • Planning ahead. You track what is coming up per country and plan renewals on time. Outside the EU that means six to nine months ahead.
  • New registrations. You compile and submit dossiers for products that sales wants to bring to your markets.
  • Site transfer. You transfer the registrations in your countries to our new manufacturing site. This is the main project in Regulatory Affairs right now.
  • Daily questions. You answer questions from sales, operations, customers and agents. You reach customers by email, phone or WhatsApp, whatever works for them.
  • Changing rules. Requirements change per country, also outside the EU. You follow up, get confirmation on how to proceed and keep your dossiers in line.
  • Working across the company. You work with QA, QC, logistics, marketing and sales, so products can be registered, released and shipped.

Over de werkgever

Over Interchemie

Interchemie is een internationaal opererende familieonderneming die diergeneesmiddelen, nutritionals en desinfectiemiddelen ontwikkelt en produceert. Vanuit het hoofdkantoor in Waalre en productielocaties in Nederland, Estland en Litouwen bedient Interchemie klanten in meer dan 100 landen via zorgvuldig geselecteerde distributeurs. De afgelopen jaren laat Interchemie een structurele groei in dubbele cijfers zien.
Recent hebben Interchemie en Kepro de handen ineengeslagen. Kepro is eveneens actief in diergezondheid en heeft een sterke internationale positie, met name in Afrika en het Midden- Oosten. Door deze overname zijn kennis, portfolio en commerciële slagkracht verder versterkt en ontstaan nieuwe groeikansen in bestaande en nieuwe markten.
De gezamenlijke ambitie is helder: verdere uitbouw van het marktaandeel in strategische regio’s, met Afrika als belangrijk speerpunt. Betrouwbaarheid, kwaliteit en langdurige samenwerkingen met distributeurs staan daarbij centraal.

Wat krijg je

  • Your own countries. You own the registrations in your countries, from first registration to renewal.
  • A salary between €3,784 and €5,297 gross per month, depending on your experience.
  • 25 vacation days and 8.25% holiday allowance.
  • A pension scheme with an employer contribution that grows with your age, up to 26%.
  • Travel allowance of €0.23 per km, from the first kilometre.
  • A field where you keep learning. The medicine itself, the full product lifecycle and rules that keep changing. As our colleague Anton puts it: "You will never know enough."
  • English as working language. Dutch is not required.
  • A position on site in Waalre, preferably full-time.

Wat vragen we

  • A Master's degree in life sciences, chemistry or pharmacy.
  • Two to three years of experience in a pharmaceutical environment such as a lab, QA, QC or a pharmacy, so you know how pharmaceutical production works. Experience in Regulatory Affairs is a plus. Medical devices experience does not fit this role.
  • You take responsibility without being asked and want to understand why a requirement exists.
  • You are precise and patient. Some registrations take years.
  • You choose Regulatory Affairs as your field and want to grow in it.
  • Fluent English. Spanish is a plus.
  • You live within one hour of Waalre and work on site.

Klaar voor de volgende stap?

Give shape to Animal welfare

Laat je cv achter voor de functie Regulatory Affairs Specialist, de koffie staat klaar.

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