Job Description

Overview

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

Be at the forefront of bringing life-changing medicines to patients. As Director of Development & Product Strategy at Kyowa Kirin, you will take on a highly visible regulatory leadership role where your strategic thinking, scientific insight and influencing skills will help shape the future of innovative therapies. Acting as a Global Regulatory Lead and/or Regional Regulatory Lead, you will drive bold, smart and commercially aware regulatory strategies across development projects and licensed products, partnering with talented cross-functional teams to unlock opportunities, navigate complexity and maximise impact for patients worldwide.

Responsibilities

Key Responsibilities

• Lead the design and delivery of ambitious global and/or regional regulatory strategies that accelerate development, strengthen product value and support successful patient access.
• Bring regulatory expertise to the heart of cross-functional decision-making, helping teams identify opportunities, solve challenges and turn complex plans into action.
• Drive high-quality global regulatory submissions, marketing applications and key post-approval activities with confidence and clarity.
• Represent regulatory strategy in health authority interactions, negotiations and agency meetings, shaping discussions that matter.
• Keep momentum across regulatory timelines, external partnerships and project activities, ensuring priorities stay focused and delivery stays on track.
• Provide trusted leadership across due diligence, inspections, audits, compliance and process improvement, raising standards and strengthening ways of working.
• Inspire, mentor and support colleagues by sharing insight, best practice and a strong strategic regulatory mindset.

Qualifications

Position Requirements

• Life science qualification with substantial pharmaceutical regulatory affairs experience and the confidence to operate at a senior strategic level.
• Strong command of global regulatory requirements, with the ability to turn complex guidance into clear, forward-looking strategy.
• Proven experience leading marketing applications, health authority negotiations and impactful regulatory interactions.
• Experience across EEA+, North America and/or Japan regulatory environments would make you stand out.
• Knowledge of oncology, bone and mineral and/or rare disease products would be a strong advantage.
• A strategic, collaborative and influential style, with excellent communication, negotiation and project leadership skills.
• Ability to travel locally and internationally, including overnight stays when required.

If you are ready to shape strategy, influence global outcomes and help deliver medicines that make a real difference, we would love to hear from you.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.