Associate Director, Global Regulatory Affairs Compliance and Training Team Lead

Job description

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Director, GRA Compliance and Training Team Lead, provides strategic leadership for the GRA Compliance & Training function, defining vision, priorities, and resource allocation to support organizational objectives. This role leads and develops a high-performing team, oversees global compliance frameworks, SOP governance, inspection readiness, and regulatory risk management. The Director drives the global training strategy, optimizes SOP processes, and collaborates cross-functionally to ensure consistent, integrated compliance standards. Key responsibilities include monitoring compl...