Job Title: |
Associate Director (AD), Regulatory Affairs |
Location: |
Beijing |
Major Responsibilities and Duties
- Review product registration dossier and relevant documents
- Obtain IND & NDA approval as well as product registration license renewal as planed
- Coordinate with each function within HMPL from registration pathway
- Establish and maintain relationship with external stakeholders
- Liaise with external stakeholders for regulatory needs of HMPL
- Implement regulatory activities as required by governmental regulations and internal SOPs
- Form accelerate Strategy for product registration
Qualifications:
- Bachelor degree and above in Pharmacy or Pharmaceutical
- 7 years or more drug registration experience in pharmaceutical industry
- Prefer oncology drug registration background
- Good understanding of Chinese pharmaceutical & regulatory environment
- Good relation with stakeholders related to product registration
- Fluent English
- Strong communication skill
- Passion in drug development
Internal-External Relations
- Internal: RA team, CR team, Research dept., CMC Dept., GA Dept., etc.
- External: NMPA, CDE, NIFDC, CFDI, CHP, etc.
If interested, please forward your resume to KellyL@hutch-med.com