Shionogi Europe Careers

Description

Enabling Global Regulatory Success Through Digital Systems

At Shionogi, we are committed to enabling global health through innovation, scientific excellence, and robust regulatory operations. As our pharmaceutical portfolio continues to expand, we are using our digital systems in Regulatory Affairs to ensure our submissions, data, and systems are inspection-ready, future-proof, and globally connected.

We are now seeking an entry-level Global Regulatory Operations & Data Management Graduate to join our European Regulatory Affairs organisation. This is an exciting opportunity for a graduate with a strong interest in IT, data, and Regulated Affairs to begin a career at the intersection of regulatory science, technology, and data governance.

Why Join Shionogi?

Shionogi offers a collaborative, agile, and purpose-driven environment where technology and data play a critical role in enabling regulatory success. This graduate position is designed to provide hands-on exposure, structured learning, and close mentorship, allowing you to develop strong foundations in regulatory systems and digital operations.

From day one, you will be treated as a valued member of the Regulatory Affairs team, contributing to real projects while building skills that will support long-term career growth in regulatory operations, regulatory IT, or digital transformation.

About the Role

As a Global Regulatory Operations & Data Management Graduate, you will support the design, configuration, and optimisation of regulatory systems and data across the product lifecycle. While this is an entry-level position, it offers deep exposure to enterprise regulatory platforms, data standards, and validated IT environments.

You will work closely with colleagues across Regulatory Affairs, IT, Quality, and external vendors, acting as a bridge between business needs and system enablement.

You will:

• Support the day-to-day operation of Regulatory Information Management (RIM) and related regulatory systems.
• Assist with system configuration, user access management, workflows, and data structures.
• Help maintain high-quality regulatory data, ensuring accuracy, consistency, and traceability.
• Support integration between regulatory systems, document management platforms, and other enterprise tools.
• Contribute to system validation and compliance activities in line with GxP, Annex 11, and 21 CFR Part 11.
• Assist with reporting, dashboards, and system-driven metrics for regulatory teams.
• Support the creation and maintenance of SOPs, user guides, and technical documentation.
• Participate in digital improvement initiatives and automation projects within Regulatory Affairs.

What Are We Looking For?

This is an entry-level / graduate role, ideal for someone at the start of their career who is motivated by technology, data, and regulated environments.

You will bring:

• A degree in IT, Computer Science, Data Management, or a Life Science discipline, with a strong interest in digital systems and data.
• High computer literacy and confidence working with digital tools and structured data.
• An interest in how IT systems support pharmaceutical regulatory compliance.
• Ideally an awareness of regulatory data standards such as IDMP or SPOR.
• Strong attention to detail and a logical, structured approach to problem-solving.
• The ability to work collaboratively in a cross-functional, international environment.
• Clear and effective communication skills in English.
• A proactive mindset with a willingness to learn and develop.

Join Us

If you are a graduate with a passion for IT, data, and structured systems, and you are excited by the idea of supporting global regulatory operations in a highly regulated environment, we would love to hear from you.

Join Shionogi and become a driving force behind global regulatory success through innovative digital systems. Build a meaningful, long-term career in Regulatory Affairs and regulatory technology while making a real impact on healthcare worldwide..