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Regulatory Affairs Specialist CIS

Interchemie

Waalre
Full-time
2-5 years experience
On-site

€3,784 - €5,297 per year

Key Skills

Russian Language
English Language
Regulatory Affairs
Dossier Preparation
Veterinary Medicine Registration
Regulatory Compliance
Renewal Planning
Pharmaceutical Production
Quality Assurance
Quality Control
Cross-Functional Collaboration
Attention To Detail
Planning
Communication
Problem-Solving
Responsibility

Job Description

Regulatory Affairs Specialist CIS - Russian Speaking Your Russian opens the border. The scientist in you gets the medicine across. At Interchemie, you register veterinary medicines in the CIS countries, where a registration moves faster with someone who speaks the language. You learn the profession step by step, in a team that welcomes you and challenges you. You work in pharma: in the lab, in QA, in QC or in a pharmacy. You speak Russian. Ready for the next step? Read on. Your challenge This is your moment to step into regulatory affairs. You want to use your scientific background for more than repeating the same procedures. Here, your Russian opens the border. In several CIS countries customers do not speak English. With you, a registration moves much faster, because you can handle it in Russian, even over WhatsApp. That makes you valuable from day one. And the scientist in you gets the medicine across. You learn how a formulation works, which animals a product is for and how a withdrawal period is set. You see the full lifecycle, from production and quality control to registration and sales. As Anton, Regulatory Affairs Specialist, puts it: "You will never know enough. There is always something that you need to figure out." You step in at a moment that matters. We are moving our registrations to a new manufacturing site, and the CIS countries keep raising their requirements. Sometimes a new rule appears after a label has been approved, while the order is already waiting at customs. Sales cannot sell and operations cannot produce until you have done your part. You are the backbone that keeps products moving. And you build a career in a scarce profession. Learn regulatory affairs here and your expertise is in demand wherever medicines are made. You start with a few days of training in our systems, then small tasks in one country with a mentor, and build up to the full dossier. Main responsibilities Registration means making sure a veterinary medicine may legally be sold in a country. You translate scientific product information into a dossier that meets the requirements of that country. Your own CIS countries. You are responsible for the registrations in your countries. You start with one country, learn it step by step with a mentor, and grow to two or three. Planning ahead. Registrations have to be renewed. 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. In most CIS countries, this means compiling a complete dossier. Daily questions. You answer questions from sales, operations, customers and agents, often in Russian. Changing rules. Requirements change per country. You follow up, agree with agents 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. About Interchemie Interchemie develops, produces and distributes veterinary medicines, nutritionals and disinfectants. Founded in 1979, we now bring more than 100 products to over 120 countries from our headquarters in Waalre. Everything we make is produced under GMP and GMP+. In 2025 Interchemie, Kepro, Alfasan and Pharmapark joined forces into one group under the Interchemie name. Since then we have been investing in compliance, safety, quality and growth. Pharmapark in Tallinn is the newest and largest pharmaceutical manufacturer in Estonia. For Regulatory Affairs, that means a growing workload and a new manufacturing site. We are an international and multicultural organisation, with colleagues from many different backgrounds. Lines are short and responsibilities are clear. The Regulatory Affairs team works in English, on site in Waalre, together with remote colleagues who help prepare the dossiers. You meet weekly and work closely with QA, sales, marketing and IT. Decisions are made fast: when something needs to happen, we act. When one country becomes urgent, the team works on it together. And the door of the RA Manager is open when you want to think something through. You join the CIS team of three, with team leads in the Netherlands and Ukraine. AI is already part of the daily work, for translations and pharmacovigilance. Hetika, our RA Manager, has worked here for fifteen years and says her job has never been the same. We offer Your own CIS countries. You own the registrations in your countries, growing from one to two or three. 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. A structured start. Training in our systems, then step by step into your first country with a mentor. A scarce profession. Expertise in regulatory affairs is in demand wherever medicines are made. English as working language. Dutch is not required. A position on site in Waalre, preferably full-time. We ask Very good Russian (Russian or Ukrainian background) and fluent English. 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. You live within one hour of Waalre, or are prepared to move closer. Apply Ready to open the border? Apply via the button. You will hear from us within a few working days. Questions first? Email Lynn van Wonderen at [email protected].

Core Responsibilities

Manage veterinary medicine registrations for assigned CIS countries, including preparing and submitting dossiers, planning renewals, and transferring registrations to a new manufacturing site. Monitor changing country requirements and coordinate with agents and internal teams to support product registration, release, and shipment.

Requirements

Candidates need very good Russian, fluent English, and a master's degree in life sciences, chemistry, or pharmacy, along with two to three years of experience in a pharmaceutical environment such as a laboratory, QA, QC, or pharmacy. Regulatory Affairs experience is a plus; candidates should be precise, patient, proactive, committed to the field, and live within one hour of Waalre or be willing to relocate closer.

Benefits

  • Salary Of €3,784–€5,297 Gross Per Month
  • 25 Vacation Days
  • 8.25% Holiday Allowance
  • Pension Scheme With Employer Contributions Up To 26%
  • Travel Allowance Of €0.23 Per Kilometer
  • Structured Training And Mentorship
  • Professional Development In Regulatory Affairs

About Interchemie

Industry: Veterinary Services

Company size: 51-200 employees

Interchemie werken ‘De Adelaar’ B.V. was founded on the 19th of January 1979 in Castenray, the Netherlands. From its humble beginnings in The Netherlands, Interchemie is now supplying partners worldwide with veterinary products including veterinary medicines, feed additives, pesticides and disinfectants. We offer our products to careful selected distributors worldwide in Europe, Asia, Africa, South America and the Middle-East. It is our mission to provide products by people you can rely on. We want to establish the same high quality in each and every one of our products. This is our obligation to both our customers and their animals. To fulfill this mission our factories produce veterinary medicines according to G.M.P. regulations and feed additives according to G.M.P. + regulations. Our facilities are inspected yearly by our authorities which results into full G.M.P. approval and G.M.P. + approval. To meet the clients demand we offer customized labeling and legitimate registration of every medicine, complying with international rules and regulations. Interchemie has attained this high quality standard by continuously researching and developing new products. Because only by improving our product line we can safeguard the health of animals in the future. Our high standard are also reflected by our employees. We believe our people should be just as reliable as our products. The ongoing demand of our customers worldwide requires a trustworthy team and clear communication. Interchemie offers reliable and efficient customer service while working together with many partners around the world. We realize that knowledge sometimes helps more than only offering a solution. Preventing the problem before it arises is why Interchemie not only provides veterinary medicines, but also manufactures feed additives to keep animals healthy.

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