Regulatory Affairs Lead

Orion Corporation; Espoo; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Orion Pharma is seeking a Regulatory Affairs Lead to develop and implement regulatory strategies for a broad human pharmaceutical portfolio. You will provide regulatory direction, coordinate authorities, and lead cross-functional teams in lifecycle management.

The role is permanent and full-time, based in Espoo or Turku with Orion’s hybrid working model, reporting to the Head of Global Regulatory Affairs, LCM, and requiring about 10 years in regulatory affairs and an MSc in Pharmacy or Life

Qualifications

• M.Sc. in Pharmacy, Life Sciences or related field.
• About 10 years in regulatory affairs for pharmaceutical products.
• Strong knowledge of European pharmaceuticals legislation and procedures.
• Excellent communication and teamwork in international settings.
• Fluent written and spoken English; Finnish is a plus.

Responsibilities

• Shape regulatory strategies across a broad product portfolio.
• Lead regulatory activities and interactions with authorities.
• Develop and improve regulatory processes and ensure GxP compliance.
• Coordinate cross-functional teams and partner with external bodies.

Skills

Regulatory affairs

Pharmaceutical knowledge

Regulatory strategy

English proficiency

Finnish language

Education

M.Sc. in Pharmacy/Life Sciences

Job description

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.

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

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, Health and Safety), CPD&LCM (Commercial Product Development & Product lifecycle management) and Operations Development.

The Global Regulatory Affairs, LCM department is part of Commercial Product Development and Lifecycle Management within Orion Global Operations. The department leads regulatory affairs activities for Orion’s branded and generic products throughout their lifecycle after the development phase. You will become part of a community of approximately 20 regulatory professionals in Finland, working closely with colleagues in our Mumbai office, local subsidiaries and a global network of regulatory consultants.

About Us

Orion 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.

• Full time