PRIMARY FUNCTION :
- Regulatory Affairs
- 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.
- 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.