Summary of Job Responsibilities:
- Responsible for the lifecycle maintenance, new indications as well as the early developing product under the scope of Oncology (Hematology) covering both small molecule and biological product.
- Closely connection with regional and global stakeholders to development competitive registration strategy.
- Lead HA interaction, ensure timely and qualified filing and response to HA queries.
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- Lead for in country QC testing to support the Filings.
- Keep good relationship with authority and key stakeholders.
- Perform with high quality and compliance.
Dimensions of Job:
- Support new pipeline and life cycle maintenance for Business growth
- Sharing and coaching junior team members and continuously contribute team’s performance improvement.
- Credo based behavior with regulatory compliance excellence.
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, cross-functional collaboration, as active contributor in some policy work
Qualifications
- A Bachelor’s degree or above, major in a related life-science discipline.
- > 5 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.
- Experience in working in project teams and/or a matrix organization, and the regulatory experience in Oncology Therapeutic Area is preferred.
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