Director, Regulatory Affairs

Shape the Future of Healthcare with Shionogi

At Shionogi, we are dedicated to improving the health and well-being of people around the world. As a leading pharmaceutical company, we are committed to innovation, excellence, and making a positive impact on global healthcare. Join us in our mission to shape the future of healthcare and make a difference in the lives of millions.

Why Choose Shionogi?

Shionogi offers a dynamic, collaborative work environment where you can grow your career and contribute to ground-breaking healthcare advancements. We value diversity, inclusion, and the unique perspectives that each team member brings. At Shionogi, you will have the opportunity to work with talented professionals, engage in meaningful projects, and be part of a company that is at the forefront of medical innovation.

About the Role

As Director of Regulatory Affairs, you will oversee EU regulatory activities for assigned products and new developments, providing guidance, direction, and support on regulatory and submission strategy and planning. You will collaborate closely with global regulatory colleagues and project team members in Japan and the US. With appropriate experience, you can have the opportunity to interact globally for assigned products. Your responsibilities will include:

• Leading the preparation of key regulatory documents
• Managing interactions with European regulatory agencies
• Supporting post-marketing licensing requirements
• Mentoring internal and external parties

What are we looking for?

We are seeking a highly experienced and strategic individual with:

• Experience leading regulatory development and post approval projects in the pharmaceutical or biopharmaceutical industry
• Track record of regulatory submissions and approvals
• Direct interactions with EMA and other health authorities
• Demonstrated knowledge and experience of product development with a focus on regulatory mechanisms for expedited product approval and clinical trial oversight
• Solid understanding of the regulatory requirements for products in the post-marketing phase
• Strong strategic thinking, communication, and influencing skills
• Proactive, innovative, and solution-oriented mindset

Join Us

If you are driven to make a tangible difference, please apply. Together, we can forge a path to a healthier world.