Regulatory Director, Global Regulatory Affairs

Biosion
Management
Not Mentioned
Other
18 May 2022

We are recruiting a Regulatory Director for Global Regulatory Affairs to help create and manage the regulatory submissions in the US, China, Australia, and Europe of our biologic pipeline assets in immunotherapy of oncological diseases.  Biosion is an “IN GLOBAL FOR GLOBAL” biotechnology company located in both the U.S. and China. Our highly experienced and world-class Discovery and Development teams are committed to delivering “Innovation for Cures” for patients worldwide.

 

Although the Biosion US office is located in Delaware, currently, most of the work is conducted remotely due to the pandemic.  The job requires domestic as well as international travel, 2-3 times per year and 1-2 weeks each time.  As a highly experienced individual for regulatory affairs, this position has the opportunity to take part in the company’s success through the Biosion Employee Stock Option Plan, along with an attractive salary and benefits package.

 

Main Responsibilities

  • Draft the regulatory documents such as cover letters, meeting minutes, background package for Pre-IND, summary modules for the IND/CTD, and other required regulatory documents.
  • Engage with key Health Authorities to enable successful regulatory filings and manage ongoing meetings and communications.
  • Coordinate regulatory activities internally across the portfolio as well as externally with consultants and biotech/pharma partners.
  • Coordinate efforts across a global Regulatory Affairs team in the U.S. and China.

 

Job Qualification

  • Professional degree in biomedical sciences and clinical medicine, such as pharmacy, biology, immunology
  • Excellent oral and written communication skills with successful presentation capabilities
  • Experience in regulatory activities in a biotech/pharmaceutical company, CRO or Health Agency
  • Experience in team management and coordination
  • Scientific knowledge in immunology and/or oncology preferred.
  • Bilingual English-Chinese/Mandarin speaking, reading and writing preferred.
  • One or two references upon request

 

Contact

Please contact Yao-Yao Zhu, MD, Ph.D., Head, Global Regulatory Affairs , Biosion, USA, Inc. to learn more about this opportunity. WeChat ID: yao-yao_zhu or [email protected]

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