Senior Director, GRA Development & Product Strategy Team Lead (Bone & Mineral)
The Senior Director, GRA Development & Product Strategy Team Lead (Bone & Mineral) at Kyowa Kirin North America is a senior leadership role focused on driving regulatory strategy and leading global regulatory affairs activities for bone and mineral therapeutic area products. The position is part of the Global Regulatory Affairs (GRA) division, a core team that guides Kyowa Kirin’s innovative product pipeline and ensures successful product development through regulatory compliance. The role supports Kyowa Kirin’s mission to deliver life-changing therapies in specialty disease areas across North America and globally.
This individual will lead regulatory strategy development from early development through lifecycle management, collaborating with cross-functional teams to develop and implement regulatory plans. Key responsibilities include representing regulatory affairs in global teams, preparing and overseeing regulatory submissions, engaging with US and international health authorities, and ensuring consistency with organizational business objectives. The role oversees regulatory deliverables for investigational and marketed products, managing complex regulatory projects and directing a team of regulatory professionals.
The ideal candidate holds an advanced degree in a scientific discipline and has extensive experience (usually 12+ years) within regulatory affairs in the pharmaceutical or biotechnology industry, with a clear track record in the bone and mineral therapeutic area preferred. Strong leadership and team management skills are critical, alongside deep knowledge of regional and global regulatory requirements. Excellent written and verbal communication abilities, experience interacting with major health authorities, and proven project management skills are essential.
Kyowa Kirin North America offers a competitive compensation package including a comprehensive range of health, wellness, retirement, and performance incentives. Employees benefit from professional development programs, flexible working arrangements, and a supportive network in a growing international company.
Kyowa Kirin is dedicated to a collaborative and innovative workplace culture that values diversity, scientific excellence, and patient-focused solutions. As part of a global organization, the company offers significant opportunities for career growth and learning, making this role ideal for experienced regulatory leaders seeking meaningful impact in a science-driven environment.