Department of Pharmacy Practice | Pharmaceutical Fellowship Program
Department of Pharmacy Practice | Pharmaceutical Fellowship Program
Pharmaceutical Fellowship Program

Kyowa Kirin, Inc.

Global Regulatory Affairs Fellowship

 

Location: Princeton, NJ
Not Recruiting for 2027-2028 Cycle

 

Kyowa Kirin is a Japan-based global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation. Our team is working to develop the next generation of antibodies and cell and gene therapies, and we aim to deliver life-changing value to patients with high unmet medical needs with a focus on bone and mineral disorders, hemato-oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites our efforts across four regions worldwide. Through collaboration, we accelerate development by partnering with industry, academia, patients, and healthcare providers. Learn more: www.kkna.kyowakirin.com.
 

The two-year fellowship at Kyowa provides hands-on global experience within the Regulatory Affairs Development & Product 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 and will primarily focus on Regulatory Strategy and also encompass aspects of Regulatory Operations, Regulatory Policy & Intelligence, Labeling, Advertising and Promotion, 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