Job Description

Shaping Regulatory Strategy and Enabling Global Drug Development

At Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence. As our European development portfolio continues to grow, we are strengthening our regulatory capabilities to support successful product development and approvals across multiple therapeutic areas.

We are now seeking an Associate Director/Director, CMC Regulatory Affairs to lead strategic and operational regulatory activities across our development portfolio. This is a pivotal role with responsibility for defining CMC regulatory strategies, supporting global submissions and ensuring successful lifecycle management of products across the EU and beyond.

Why Join Shionogi?

Shionogi offers a purpose-driven, agile environment where individuals are empowered to make a meaningful impact. This role provides high visibility across global development teams, close collaboration with senior leadership, and the opportunity to influence regulatory strategy across multiple programmes and markets.

About the Role

As Associate Director/Director, CMC Regulatory Affairs, you will lead and oversee CMC regulatory strategy and execution across assigned products and projects This is a global role and therefore will allow the successful applicant to expand their knowledge from a core European focus. The role supports both projects in the development setting as well as lifecycle activities for approved products

Key responsibilities include:

• Leading CMC regulatory strategy for development programmes and marketed products to support successful approvals
• Overseeing the preparation and review of CMC documentation for regulatory submissions, including CTAs, IMPDs, MAAs and lifecycle variations
• Advising cross-functional teams on CMC regulatory requirements, guidelines and agency expectations
• Supporting interactions with health authorities, including preparation for scientific advice and regulatory meetings
• Anticipating regulatory risks and ensuring mitigation strategies are in place to support business objectives
• Collaborating with global stakeholders across Europe, the US and Japan within multidisciplinary teams
• Contributing to regulatory process improvement initiatives and maintaining up-to-date regulatory intelligence

What Are We Looking For?

We are looking for a Regulatory CMC scientist who can operate effectively in a complex and evolving global environment, balancing scientific, regulatory and business priorities.

You will bring:

• Senior level experience in CMC regulatory affairs within the pharmaceutical or biopharmaceutical industry
• Ideally having a scientific background from previously working in a quality control, formulation development or medicinal chemistry. Exposure to biologics would be adventitious
• Proven track record in developing and executing regulatory strategies across EU and global markets
• Strong experience in preparing and reviewing CMC documentation for regulatory submissions and lifecycle management
• In-depth knowledge of EU/EMA regulatory requirements and CMC/quality guidelines
• Ability to assess regulatory risk and develop mitigation strategies to support successful approvals
• Strong cross-functional collaboration, stakeholder engagement and influencing skills
• Excellent communication skills with the ability to operate effectively across global teams

Join Us

Join Shionogi and play a defining role in shaping regulatory strategy and enabling the successful development and approval of innovative medicines. If you are motivated by scientific excellence, global collaboration and making a meaningful impact in healthcare, we would welcome your application.