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Job Description
Job Description:
Regulatory Affairs Lead, China PDT is responsible for supporting the PDT BU’s global plasma sourcing strategy for China. S/he also leads local regulatory policy initiatives related to plasma and plasma sourcing to help ensure network flexibility and continuous supply of PDTs to patients in need in China.
The Regulatory Affairs Lead, China PDT:
- Provides proactive leadership, strategic guidance and oversight for the human plasma sourcing group by defining and optimizing regulatory strategies, objectives, and policies for the development, registration and lifecycle management of source plasma in China RA team.
- Serves as the primary contact with China HA, including NHC,NMPA, NIFDC, SHIDC, and global plasma sourcing stakeholders.
- Maintains a strong and proactive communication channel with China Health Authorities on all plasma sourcing related matters.
- Closely collaborates with the Global Plasma & RA CMC Team on regulatory plasma-related strategy issues, bringing innovative and timely approaches to regulatory and compliance requirements for existing and future products.
- Manages all aspects of plasma sourcing relative to local variation submissions, operations, tracking and approvals to ensure consistency with global strategy, and on time approvals from the HA.
- Builds and maintains a strong communication/discussion line with global PDT RA teams to ensure alignment and harmonization of FDA, EMA and NMPA regulatory requirements and regulatory policy initiatives.
- Enhances the awareness of China plasma sourcing regulations and intelligence, and hosts plasma sourcing communication meetings/education sessions, with key PDT stakeholders as global PDT RA, GMS, SITE, GQ, and other relevant stakeholders.
Locations
CHN - Beijing - Commercial
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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