Development Manager, Regulatory eTools

Orion Pharma; Espoo; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Orion Pharma is seeking a Development Manager, Regulatory eTools to lead digital transformation in regulatory operations. You will work on Product Information Management and eCTD publishing, developing Orion's ePI capabilities and regulatory systems.

The role spans Finland with offices in Espoo or Turku, offering a hybrid model for a two-year fixed-term contract. You will collaborate across a global network to shape future regulatory workflows and solutions.

Qualifications

• Bachelor's or professional background in Pharmacy or Life Sciences and related fields.
• Interest in product information management and digital regulatory solutions.
• Basic understanding of eCTD structure and regulatory publishing.
• Strong organizational skills and ability to work independently.
• Fluent Finnish and English; Swedish is a plus.

Responsibilities

• Participate in the implementation and maintenance of regulatory process databases, platforms, and digital solutions.
• Contribute to development, documentation, and training of new processes.
• Create, update, review and coordinate Product Information content across product lifecycle.
• Publish regulatory submissions in line with eCTD requirements.
• Monitor evolving regulatory requirements and communicate impacts.
• Drive problem solving, process improvement, and system development activities.

Skills

Digitalization interest

Product information management

Computerized systems

Strong communication

Collaborative approach

Finnish language

English language

Swedish language advantage

Education

Academic background in Pharmacy / Life Sciences

Tools

Regulatory databases

eCTD publishing tools

Job description

Job Description

As a Development Manager, Regulatory eTools at Orion Pharma Headquarters, you will be at the forefront of the digital transformation of regulatory operations. Your role will combine two key areas, Product Information Management and Regulatory Publishing, and you will develop Orion’s capabilities for electronic Product Information (ePI), eCTD publishing and the regulatory systems and processes supporting them.

As a subject matter expert, you will help turn evolving regulatory requirements into sustainable systems, processes and ways of working. Working closely with regulatory colleagues, internal and external stakeholders and system providers, you will support the implementation and continuous development of new solutions. You will join the Product Information team in Finland and play an important role in strengthening our future digital regulatory landscape.

This position is a two-year fixed-term position, offering an opportunity to contribute to a significant transformation in Orion’s digital regulatory capabilities. You can be located either at Espoo or Turku office in Finland, and we offer a hybrid working model.

Responsibilities

• Participating in the implementation and maintenance of regulatory process related databases, platforms, and digital solutions
• Contributing to the development, documentation, and training of new processes
• Creating, updating, reviewing, and coordinating pharmaceutical Product Information content throughout the product lifecycle in collaboration with Orion's international network
• Publishing regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements
• Monitoring evolving regulatory requirements and proactively communicate their impact
• Driving problem solving, process improvement, and system development activities

What You Can Expect From Us

We offer a varied and meaningful role where product information expertise meets digital transformation. You will have the opportunity to contribute to the development of Orion’s future capabilities in electronic Product Information (ePI) and regulatory publishing, and to work with systems, processes and technologies that are transforming regulatory operations.

You will work with a wide network of colleagues, experts and external partners in an international environment, with the support of a collaborative team. The role provides an excellent opportunity to expand your expertise, take on new challenges and play an active part in shaping future regulatory ways of working at Orion.

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 a strong interest in digitalization, product information management and computerized systems with a collaborative, proactive and solution-oriented approach. You are curious about new technologies and able to learn and adopt them quickly. Strong communication skills, together with the ability to collaborate effectively across global networks, will help you to succeed in this role.

For This Role, You Have

• Relevant academic background and/or professional experience in areas such as Pharmacy, Life Sciences, Humanities, or other fields
• Interest in product information management, structured product data and digital regulatory solutions
• Basic understanding of eCTD structure and regulatory publishing
• Strong organizational skills, initiative, and the ability to prioritize and work independently
• Fluent Finnish and English language skills, Swedish language skills are considered a significant advantage
• Experience in the pharmaceutical and/or healthcare industry is considered a strong advantage

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 industrialization of new products and product life cycle 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 organization 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.