Kyowa Kirin, Inc.

Global Regulatory Affairs Fellowship

Location: Princeton, NJ
Not Recruiting for 2024-2025

View Kyowa Kirin Brochure

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we use cutting-edge research technology, including antibody engineering to advance new discoveries that can help patients and families living with serious and rare diseases, for which there are currently no adequate treatments. Around the world, nearly 6,000 Kyowa Kirin colleagues are working from early-stage discovery through development and commercialization to surmount the challenges of innovating in new frontiers. In our labs, we’re exploring new modalities with potential applications across a broad range of targets and diseases. Our successes have produced a portfolio of specialty medicines marketed in four regions worldwide, including Japan, Asia Pacific, EMEA (Europe, Middle East and Africa), and North America.

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