In This Section
- Medical Information/ Medical Affairs — Johnson & Johnson Consumer Inc.
- Medical Information and Payer/Health System — Janssen Scientific Affairs
- Medical Information/ Medical Affairs — CSL Behring
- Medical Information — Biohaven Pharmaceuticals
- Medical Affairs — Biohaven Pharmaceuticals
- Medical Information & Medical Affairs — Incyte Corporation
- Multidisciplinary — Genmab US, Inc.
- Global Regulatory Affairs — Kyowa Kirin Pharmaceutical Development, Inc.
- Biologics Product Development & Investigational Drug Trial Design and Management — Janssen Research and Development
- Fellowship Alumni
- Eligibility and Application Process
Global Regulatory Affairs Fellowship
Kyowa Kirin, Inc.
Kyowa Kirin, Inc. (Kyowa Kirin North America; KKNA) is part of the Kyowa Kirin Group Companies which are dedicated to improving quality of life by answering the unmet medical needs of people worldwide. Based in the US, Kyowa Kirin Inc. is a specialty pharmaceutical Company contributing to human health and well-being 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 KKNA 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 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
- 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.
Daria Polyarskaya, PharmD, MHA
Rosalind Franklin University of Medicine and Science College of Pharmacy, Class of 2021
Director, Industry and Education Fellowship Programs
600 South 43rd Street
Philadelphia, PA 19104-4495