Project Manager, Regulatory Affairs (Clinical and CMC)

Title: Project Manager, Regulatory Affairs (Clinical and CMC)

Location: Remote
Employment Type: Contract

Compensation

Pay Range:$49.00-$70.00 Per Hr

Job Summary

This is a remote contract position focused on managing regulatory affairs projects related to clinical and CMC processes. 
The role involves implementing a chromatography data system, ensuring compliance with regulations, and collaborating with various stakeholders. 
A strong understanding of life sciences and regulatory principles is essential.

Key Responsibilities
Manage the implementation of a chromatography data system.
Develop and execute validation documentation.
Perform testing and support defect resolution.
Ensure systems comply with GxP regulations.
Collaborate with quality, IT, business stakeholders, and vendors.

Qualifications
Experience in life sciences with a strong understanding of GxP regulations.
Experience in validation activities, including documentation and testing.
Ability to work independently and in collaboration with cross-functional teams.
Experience with chromatography data systems preferred but not required.
Familiarity with systems used in clinical research and development is a bonus.

Core Technologies
Chromatography Data System | Validation Tools

Contact Authorization

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Benefits

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Onboarding Expectations

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EEO Statement

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