WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

An experienced regulatory professional responsible for the strategic leadership of the GRA Compliance & Training function by defining vision, priorities, and resource allocation aligned with organizational goals. Lead and develop the team, oversee global compliance frameworks, SOP governance, inspection readiness, and regulatory risk management. Direct global training strategy, drive SOP optimization, and collaborate cross‑functionally to ensure integrated compliance standards. Monitor compliance and training KPIs, enable audit readiness, manage change initiatives, and foster a risk‑aware culture across GRA.

Key Responsibilities:

• Provide strategic leadership for the GRA Compliance & Training function, defining vision, priorities, and resource allocation aligned with corporate strategy and GRA objectives.
• Lead and develop the Compliance & Training team, setting clear objectives, building capability, and fostering a culture of accountability, continuous improvement, and compliance excellence.
• Establish and maintain global compliance frameworks and governance, ensuring adherence to applicable regulatory requirements, corporate policies, and internal procedures.
• Oversee SOP governance and regulatory process standards, ensuring globally consistent regulatory practices while enabling appropriate regional implementation.
• Lead regulatory compliance risk management, including oversight of the GRA risk register, proactive identification of risks, and implementation of effective mitigation and corrective actions.
• Ensure global inspection and audit readiness, coordinating preparation for regulatory authority inspections and supporting internal and external audits.
• Drive global training strategy and capability development for GRA staff, including compliance training, role-based learning programs, and long-term capability building.
• Partner cross-functionally with key stakeholders (e.g., QA, PV, IT and other relevant functions) and external partners to ensure aligned compliance standards and effective regulatory operations.
• Monitor compliance and training performance, including defining KPIs, providing governance reporting to senior leadership, and driving continuous improvement across GRA.

Position Requirements

• Life science qualification or other relevant qualifications for role with experience in pharmaceutical regulatory affairs.
• Good leadership skills.
• Higher negotiation, verbal and written communication and interpersonal skills.
• Higher analytical and problem-solving skills.
• Higher organisational skills and attention to detal.
• Ability to understand and present more developed scientific arguments.
• Maintain as part of the whole regulatory team Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.

Kyowa Kirin International is an equal opportunity employer.

No agencies please.