Offer summary

Qualifications:

8-10 years of relevant experience, Fluency in English.

Key responsabilities:

Implement CFDA registration projects

Develop strategies for product line and DMFs/Drug Product applications

Support decision-making on DMFs and drug development

Collaborate with stakeholders to address timely issues and ensure Regulatory compliance

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Job description

Senior Manager Regulatory Affair

A well-known large healthcare company is hiring for Senior Manager Regulatory Affairs to implement CFDA registration projects, make strategy for product line and DMFs and Drug Product applications.. Responsibilities include:

Technically and strategically support decision making on DMFs & drug development
Compile filing data to obtain CFDA certificates /approvals
Work with stakeholders for follow up and resolution of timely issues
Ensure enhancing Regulatory compliance throughout development and the commercial life cycle
Manage other stuff like promotional materials review, standard compiling, product labeling, local-test designs, data analysis

Requirements