Kyowa Kirin, Inc.

Global Regulatory Affairs Fellowship

Location: Princeton, NJ
Recruiting: 1 Position for a 2-Year Fellowship

View 2025-2027 Kyowa Kirin Brochure

Posted September 2024

Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by a severe or rare disease. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International.

The two-year fellowship at Kyowa provides hands-on global experience within the Regulatory Affairs Strategy group allowing the fellow to develop a comprehensive understanding of the regulatory drug development process from early stage to post-marketing. The fellowship will span across various therapeutic areas including oncology, immunology, central nervous system and nephrology, and will primarily focus on Regulatory Strategy and also encompass aspects of Regulatory Operations, Regulatory Intelligence & Policy, Labeling, Advertising and Promotion, Compliance & Planning, and Regulatory Chemistry Manufacturing & Controls.

Global Regulatory Affairs

• Support development of global and regional regulatory strategies, as well as identify risks and their mitigation for assigned investigational and postmarketing products at all lifecycle stages while ensuring commercial objectives are met
• Participate in authoring of and/or review of regulatory documents which may include INDs / CTAs, NDAs / BLAs, NDS, MAAs, orphan, etc. for submission to US, Canada, and/or other Rest of World regulatory agencies
• Gain knowledge of country specific regulatory processes, regulations, and requirements
• Support regulatory lead and project team activities for formal meetings with regulatory health authorities
• Engage and collaborate cross-functionally with a variety of departments within the company
• Demonstrate excellent interpersonal skills and the ability to manage and/or lead multiple tasks