Offer summary

Qualifications:

At least 8-10 years of relevant experience in regulatory affairs., Fluency in English is required., Strong understanding of CFDA registration processes and drug development., Experience in managing regulatory compliance and product labeling..

Key responsibilities:

Implement CFDA registration projects and develop strategies for product lines.

Compile filing data to obtain CFDA certificates and approvals.

Collaborate with stakeholders to address and resolve timely issues.

Oversee the review of promotional materials and ensure compliance throughout the product lifecycle.

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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