Associate Director, GRA CMC Development

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: An experienced and autonomous regulatory professional responsible for independently leading CMC regulatory activities for assigned development products and clinical projects, including CGTs where applicable, while also serving as the recognized RA CMC expert for a specific product type, and/or country/region. The role provides authoritative technical and/or regional regulatory insight that is leveraged across global devel...