Associate Director (AD), Regulatory Affairs

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