Regulatory Affairs Supervisor

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PRIMARY FUNCTION :

  • Regulatory Affairs

RESPONSIBILITIES :

  • Work with RA head and liaise with HMP functional heads in developing submission strategies, work flow, and timelines.
  • Work on company registration projects as a RA team member or a project leader.
  • Responsible for executing regulatory filings, including but not limited to IND, (s)NDA, briefing book, and other HA inquiries.
  • Review and QC submission documents provided by each department to ensure the quality of submission package.
  • Coordinate and organize the authority inspections on clinical trial data and manufacturing sites.
  • Coordinate with functional heads within HMPL to address any inquiries from Chinese Health authorities.

QUALIFICATIONS :

  • At least 5 years regulatory filling experience, innovative drug IND/NDA filing experience preferred.
  • At least bachelor degree on pharmacy, clinical pharmacology or public health. Advanced degree preferred.
  • Good organization & communication skills.
  • Good understanding of regulatory policy, ICH guidelines.
  • Fluent in English.