Regulatory Affairs Lead

Your role As a Regulatory Affairs Lead at Orion Pharma Headquarters, you will have a key role in developing and implementing regulatory strategies and leading the regulatory activities across a broad and diverse product portfolio for Orion Pharma´s human pharmaceutical products. Working closely with internal functions, external partners and regulatory authorities, you will provide trusted regulatory direction and help turn complex requirements into effective lifecycle solutions. You will join a collaborative team of regulatory professionals in product lifecycle management and report to the Head of Global Regulatory Affairs, LCM. This permanent, full-time position can be based at our Espoo or Turku office in Finland and offers the flexibility of Orion’s hybrid working model. Responsibilities Regulatory Intelligence: bring strategic regulatory insight to product lifecycle management and help the organisation navigate and respond to an evolving regulatory environment. Regulatory Guidance: provide clear, practical and forward-looking regulatory guidance to product lifecycle teams. Regulatory Compliance: develop and continuously improve regulatory affairs working processes, ensuring that GxP practices, regulatory procedures, systems and processes comply with relevant guidelines. Regulatory Interactions: coordinate regulatory affairs activities internally and externally, lead communications and meetings with regulatory authorities and partners, and lead cross-functional teams and contribute as the regulatory affairs representative in teams and projects. What you can expect from us We offer a varied and influential role with challenging assignments across a broad global product portfolio. You will collaborate with a wide network of internal and external stakeholders in an international environment, with the support of a collaborative team and development opportunities aligned with your role and experience. The role provides excellent opportunities to deepen your regulatory expertise, build new capabilities and make the most of your strengths in a dynamic, results-oriented community that works closely with the business. 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/ . What are we looking for? You will thrive in this role if you combine strong regulatory expertise with a collaborative, proactive and solution-oriented approach. We are looking for: A suitable academic background, such as an M.Sc. in Pharmacy, Life Sciences or a related field Approximately 10 years of experience in regulatory affairs for pharmaceutical products, including marketing authorisation applications or variations Strong knowledge of European pharmaceutical legislation, guidance and regulatory procedures, together with curiosity about the evolving regulatory environment Excellent communication and teamwork skills, with the ability to build effective relationships in an international setting A proactive, solution-oriented mindset, sound decision-making skills and strong personal leadership Fluent written and spoken English; fluent Finnish is a strong advantage How to apply Ready to take the next step? Please submit your cover letter and CV through Orion’s recruitment system by 8 November 2026. For further information about the position, please contact Hanna Mäkiniemi, Head of Global Regulatory Affairs, LCM, by phone on +358 50 966 7406. Hanna is available on Tuesday 27 October from 8:00 to 9:00 and on Friday 30 October from 12:00 to 13:00. 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. Your new team Orion's Global Operations covers the entire pharmaceutical manufacturing process, from sourcing of raw materials to the manufacture of products, packaging and delivery to customers. We are also responsible for the industrialisation of new products and product lifecycle management. In Global Operations we have approximately 1,600 professionals working in Production, our external supplier network (Externally Sourced Operations) and Fermion Oy (API manufacturing and marketing). In addition, the organisation includes Supply Chain & Procurement, Technical Operations, Facility Management, EHS (Environment, H