Regulatory Affairs Officer

Job DescriptionAbout your roleWe are seeking a motivated and detail-oriented temporary Regulatory Affairs Officer to join our team. In this temporary role (18 months), you will be responsible for supporting the development, submission, and maintenance of marketing authorizations (MA) for rest of the world countries. Over time, you can also work for other countries. You will work closely with cross-functional teams including R&D, Quality Assurance and Manufacturing 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 related products. There is a possibility for a permanent contract afterwards.Your ResponsibilitiesPrepare and coordinate regulatory submissions. These include marketing authorization applications, variations and renewals.Write or update technical documents related to quality (p2 or Module 3)Ensure regulatory compliance of veterinary medicine product information. Be the primary contact for responding to questions from regulatory authorities and questions regarding veterinary medicines of your region internally. Collaborate with colleagues within regulatory and outside regulatory.Maintain regular contact with our distributors and where necessary, local partners, for the follow-up of regulatory issues.Develop knowledge and understanding of the registration dossier and of each regulatory submission that is done. Ensure regulatory compliance of our products by working closely with other departments, especially the quality assurance department. Submit and follow up change requests after approval of variations or other regulatory activities. Proofread and approve product information in our QMS or artwork system. Make or update regulatory affairs specifications in our QMSMake, review and approve work instructions and procedures related to regulatory in our QMS.What We OfferAn onboarding program to get you quickly up to speed. A dynamic and international work environment.Competitive salary and benefits package.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 https://www.orion.fi/en/careers/orion-as-an-employer/ .Our expectationsEssential competences, education and way of working A degree in life sciences is expected. Similar experience in regulatory affairs for human or veterinary medicines would be beneficial. Fluency in English, fluency in French is an asset. Taste for teamwork, work accurately, ability to anticipate and plan Ability to collaborate with people from various countries and cultures.How To Apply And Additional InformationPlease 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 Charlien Wouters, HR Manager.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.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 DescriptionThe 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.About UsOrion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.We offer careers with a clear purpose: empowering people to live their lives to the fullest.