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Director, Regulatory Affairs

Job Description Summary

Adagene is seeking a Director/Sr Director/Ex Director of Regulatory Affairs who will provide leadership on China and Asia Pacific Area regulatory activities. Responsibilities will mainly focus on regulatory filings and providing strategic as well as operational leadership. In addition, responsibilities will include support to on-going clinical, preclinical, and CMC activities. The candidate will supervise a regulatory team based in Suzhou.

Essential Functions

  • Develop regulatory strategies for assigned programs by analysis of guidance’s and assessment of drug developed for 、oncology indication to obtain regulatory approval in support of Adagene’s development and marketing objectives within specified timelines
  • Serve as the liaison responsible for communication with CDE and other health authorities for assigned programs
  • Manage/lead regulatory activities associated with assigned drug development programs
  • Management of the planning, preparation and submission of INDs and amendments
  • Continually monitor newly published CDE guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required
  • Manage and mentor direct reports and/or junior staff members

Qualifications

  • Bachelor’s degree in a scientific subject area and MS, PhD degree preferred
  • A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experienceExcellent written and verbal communication skills
  • Complete written and verbal fluency in Mandarin and English

Please send resumes and career related inquires to hr@adagene.com

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