Orion Animal Health is seeking to hire a Regulatory Affairs Officer to join our team of regulatory professionals!
Description of Position
The purpose of this role is to contribute to the management and support of regulatory activities for veterinary medicinal products, ensuring they meet global standards. As a Regulatory Affairs Officer you will have the opportunity to develop expertise in regulatory procedures, particularly for new marketing authorisation applications in the EU and US. You'll also gain a deeper understanding of regulatory guidelines and processes while collaborating with internal teams, and global partners. Additionally, the position involves ensuring compliance with Good Manufacturing Practices (GMP) and regulatory procedures, playing a key part in supporting the company’s broader regulatory strategy.
As a Regulatory Affairs Officer, you will play a key role in the entire lifecycle of veterinary medicinal products - from the development of new medicinal products to initial global marketing authorisation applications, market launches as well as maintaining current authorisations.
You will collaborate closely with the Orion Animal Health regulatory team located in Finland, Belgium and France, as well as with other organisations and stakeholders internally and externally.
Your main responsibilities as a Regulatory Affairs Officer will include:

• preparing administrative documentation for global regulatory submissions (e.g. Clinical Trial Authorisations, Marketing Authorisation Applications, variations) in EU, USA and elsewere
• engaging with Competent Health Authorities before and during regulatory proceedings
• preparing and updating product information materials (Summary of Product Characteristics, label, package leaflet)
• serving as a regulatory affairs expert in cross-functional teams and/or in projects
• documenting outcome of regulatory procedures in our IT-systems and request change controls
• review and approval of artwork
• coordinate regulatory procedures internally, with service providers and global partners
• follow Gx P practices, regulatory procedures, and processes

You have the opportunity to develop yourself as a regulatory affairs expert and to contribute to global regulatory strategies. This is a permanent position based in Turku, Finland.
Description of Unit
This position is located in the Regulatory Affairs & Pharmaceutical Development team, which belongs to the Animal Health R&D organisation within the Orion Animal Health Business Unit. In this dynamic cross-functional team we have experts from different areas of expertise working across different countries: Finland, France and Belgium.
Orion Corporation’s business division Animal Health (AH) comprises more than 350 employees in 11 countries. 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 Finland, France and Belgium.
Orion Corporation is a pharmaceutical company listed on the Helsinki, Finland stock exchange. Read more about Orion as an employer from the website https://www.orion.fi/en/careers/orion-as-an-employer/
We Offer
We offer you versatile, interesting and challenging responsibilities in a multi-professional and international environment. You will be part of a great team with skilled and highly motivated colleagues. Appreciation of colleagues and continuous development are part of our core values. You will have the chance to grow your skills, learn new things, and improve your strengths. We offer a supportive working environment and development opportunities.
Requirements
The ideal candidate would have the following qualifications and competencies:

• A relevant educational background, such as Bachelor’s or Master’s degree in, e.g. Pharmacy, Life sciences or Languages
• Good co-operation and team working skills, but also capability to work independently
• Strong attention to detail and precision
• Willing to stick to deadlines
• A desire to learn and grow
• Readiness to take responsibility and willingness to develop processes further
• Proactiveness and solution-orientated mindset
• Fluent communication and negotiation skills in English. Skills in other languages is an adventage
• Good skills in MS Office

Hands-on experience of regulatory affairs or other expert work in the pharmaceutical industry is considered an advantage.
Additional Information
If you think this position is made for you, please send your CV and your application no later than 17th November 2024.
Inquiries can be done by telephone: Kristina Bergström, Senior Regulatory Affairs Manager, tel. +358 50966 7618 on 4th Nov 9:00-11:30, 7th Nov 11:00-12:00 and 14th Nov 12:00-14:30.
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We will carry out a security clearance prior to the employment for the selected person.

Orion Corporation operates in more than 30 countries, where we Orionees, 3600 in total, work in all kinds of positions. Among us there are Research Scientists, Laboratory Technicians, Engineers and IT Specialists as well as people working in Production, just to mention some examples. We offer diverse and responsible jobs to our personnel in a truly multi-disciplinary work environment. We encourage people to develop their competences and offer opportunities to affect the job description and creating their own career path at Orion. We are searching for top talents who are ready to share our passion for the work that we do.