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Global Regulatory Affairs Fellowship Program

Kyowa Kirin Pharmaceutical Development, Inc.

Princeton, NJ

Kyowa Kirin Pharmaceutical Development, Inc. (KKD) is an international biopharmaceutical company dedicated to improving quality of life by answering the unmet medical needs of people worldwide. KKD is a Japan-based Global Specialty Pharmaceutical Company contributing to human health and wellbeing worldwide through innovative drug discovery and global commercialization, driven by state-of-the-art antibody technologies in the core therapeutic areas of oncology, nephrology, central nervous system and immunology.

The two-year fellowship at KKD provides hands-on global experience within Regulatory Affairs 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 therapeutic areas including oncology, immunology, and nephrology, and will encompass aspects of Regulatory Strategy, Regulatory Intelligence, and Regulatory Chemistry Manufacturing and Controls. 

Global Regulatory Affairs

  • Develop a strong global regulatory strategy skillset while actively contributing to regulatory planning, strategy, and filings to support company assets.
  • Develop the ability to assess development programs from a regulatory perspective.
  • Proactively identify regulatory issues impacting program progress and development and advise management on resolutions.
  • Obtain knowledge of country specific regulatory processes, with focus on FDA and EMA regulations and requirements.
  • Interpret local and global regulations and apply interpretative analyses of key regulatory guidance documents as they relate to ongoing projects and submissions.
  • Engage and Collaborate cross-functionally with a variety of departments within the company as a partner in the drug development process.
  • Cultivate strong communication, leadership, and time management skills.

Contact:

James M. Hollands, PharmD, BCPS
Director, Industry and Education Fellowship Programs

Address:

University of the Sciences, Philadelphia College of Pharmacy
Box 34
600 South 43rd Street
Philadelphia, PA 19104-4495

Phone:

215-596-8882

Email:

j.hollands@usciences.edu