Director, Development & Product Strategy

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.

• →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.

• 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.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.