Vacancy Regulatory Affairs Specialist Estonia
Join the Interchemie family where you’ll specialize (further) in Regulatory Affairs. In this pivotal position, you work closely with stakeholders: colleagues, clients, agents, and health authorities. Our unique product portfolio of veterinary pharmaceuticals, produced under GMP and GMP+ standards and sold globally, offers a challenging and fulfilling Regulatory Affairs role where you’re involved in projects from A to Z.
Your Position
Instead of focusing on just one aspect, as a Regulatory Affairs Specialist at Interchemie, you and your 5 colleagues (in Estonia) are responsible for the full regulatory cycle of a wide range of new and existing veterinary medicines and disinfectants. You’ll work at our production site in Viimsi.
Your main responsibility is to ensure complete and accurate registration dossiers tailored to the requirements of each country, based on European and Estonian legislation. This includes the preparation, submission, and maintenance of documentation for marketing authorisations, variations, and renewals, as well as advising management on regulatory topics.
Experience as a Regulatory Affairs Specialist or Officer is welcome, but not required. If you hold a Bachelor’s or Master’s degree in a relevant field such as Biology, Chemistry, Biotechnology or Life Sciences, you are more than welcome to apply. Either way, we offer a challenging role with guidance, room to grow, and the opportunity to develop professionally. Since this is a broad position, ‘ownership’ is a key concept, and your independence and sense of responsibility will be crucial.
Important Tasks
- Composing and managing registration dossiers (Part I–IV): analytical/chemical studies, toxicological studies, residue studies, and clinical studies
- Preparation and submission of applications for marketing authorisations (MAs), variations, and renewals
- Review and approval of mock-ups and product information texts
- Communication with Competent Authorities (Estonia and EU), as well as with internal and external stakeholders
- Maintenance and management of internal documentation related to MAs
- Monitoring relevant scientific literature and regulatory developments
- Advising management on regulatory actions and ensuring compliance with applicable guidelines
About Interchemie
Interchemie werken ‘De Adelaar’ B.V. was founded on January 19, 1979, in Castenray, the Netherlands. From its humble beginnings, Interchemie has grown into a global supplier of veterinary products, including veterinary medicines, nutritional products, and disinfectants. We serve carefully selected distributors across Europe, Asia, Africa, South America, and the Middle East. All our products are manufactured according to GMP and GMP+ guidelines.
Interchemie operates three production facilities with 12 production lines, including injectables, oral liquids, and water-soluble powders. Our focus on continuous innovation and product development ensures we can safeguard animal health both now and in the future.
Don’t want to miss this chance or do you have some questions? Please contact us.
