Description

Summary of Job Responsibilities:

• Responsible for the regulatory affair for IDV & Retinal TA
• Closely connection with local and global stakeholders to development competitive registration strategy
• Represent RA and provide regulatory strategy input for China compound teams; execute CTA & NDA/BLA filings; lead CDE consultation preparation activities and meeting minute’s preparation.
• Lead for in country QC testing to support the Filings.
• Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization.
• Perform with high quality and compliance

Dimensions of Job:

• Support new pipeline for Business growth
• Regulatory LCM strategy support for responsible marketed products, as well as input to BU and product teams

Principal Accountabilities of Job:

• Cooperate with global, regional, local compound team and Cross Function to establish registration plan and strategy.
• Good communication skill.
• Interact with HA division level and above.
• Actively involve into establishment and revision of regulations, guidelines.
• Develop internal SOPs and working instruction.
• Own work-related knowledge on device regulations.
• Credo based behavior with compliance manner.

Key Performance Measures:

• Regulatory strategy and timeline consistency
• Qualitative delivery without critical finding
• Good HA connection
• Others: Crisis management, people development, as active contributor in some policy work

Qualifications

• A bachelor’s degree or above, major in a related life-science discipline.
• > 8 years of regulatory affair experience in a multinational pharmaceutical company.
• Strong lobby/negotiation capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under high pressure.
• Have good communication with HA.
• Fluent English in verbal and written; good computer skill, good presentation skill.
• Rich Experience in New Compound registration is needed, and the regulatory experience in Oncology Therapeutic Area is preferred.