About your role
We are looking for a motivated and detail-oriented Regulatory Affairs Officer - Veterinary Medicines to join our team. In this role, you will be responsible for supporting the development, submission, and maintenance of marketing authorizations (MA) according to the regulations of each country in the CIS region. Initially, your focus will be on the CIS region, with opportunities to expand your responsibilities to other markets over time. You will work closely with cross-functional teams including R&D, Quality Assurance, and Sales to ensure our products meet all legal and safety requirements. The role will carry out activities to ensure regulatory compliance for veterinary medicinal products and feed additives.
Your responsibilities
* Prepare and coordinate regulatory submissions, including marketing authorization applications, variations, and renewals.
* Ensure regulatory compliance of veterinary medicine product information and approve related artwork in QMS.
* Act as the primary contact for regulatory authorities and internal queries regarding veterinary medicines in your assigned countries
* Collaborate effectively with internal teams (Regulatory Affairs, Quality Assurance, R&D and sales) and maintain regular contact with distributors and local partners.
* Develop and maintain expertise in veterinary legislation and registration dossier requirements for assigned countries.
* Write and update technical quality documents (e.g., Module 3 or P2) and maintain regulatory specifications in QMS.
What we offer
* An onboarding programme to get you quickly up to speed.
* An opportunity to work in a dynamic, collaborative environment with multiple internal and external stakeholders.
* Competitive salary, benefits, and growth opportunities within a leading company in the industry.
Orion is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
Please visit our website to find further information about our values and Orion as an employer
Our expectations
To succeed in this role, you bring the following background and skills:
* A degree in chemistry, life sciences, or a related field (e.g., laboratory techniques, biology, biomedical sciences).
* A first experience in regulatory affairs for human or veterinary medicines would be beneficial.
* Experience with CMC (module 3 or part 2) is considered a strong asset.
* Fluency in English
* Strong team player with excellent planning and accuracy skills.
* Ability to collaborate with people from various countries and cultures.
* You hold a valid work permit for Belgium and/or France.
How to apply and additional information
Please submit your resume and a cover letter detailing your relevant experience and why you are interested in this position.
If you have any questions, please contact Casper Soors, Talent Acquisition Specialist.
We typically review applications already during the application period and may start interviewing candidates before the application deadline. Therefore, we invite you to send your application as soon as possible.
#LI-ORION
Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.
Unit description
The mission of Animal Health is to improve the quality of life for animals. Animal Health manufactures and markets in-house developed medicines as well as numerous generic drugs for both companion and livestock animals. We are committed to making daily life healthier and less stressful for both animals and the people who care for them.
We produce and distribute over 300 veterinary medicines and are present in over 100 markets around the world servicing the needs of our customers in both the companion animal and livestock sectors. Our manufacturing and supply chain operations are located in France and Belgium.
Animal health is a diverse team of over 300 professionals, based in 13 countries across Europe and Vietnam. We operate as one unified team, bringing together expertise from various departments including Sales, Marketing, Operations and Supply Chain, R&D, Quality Management, HR, Finance, and IT. The Animal Health culture that we foster is one of collaboration, inclusivity, and innovation, where everyone feels empowered to contribute and challenge the status quo. We aim to prioritize the customer and work together toward shared goals.