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:
By applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. Message and data rates may apply for texts. Carriers are not liable for delayed or undelivered messages. You can access our privacy policy here
Benefits:
Learn more about our benefits offerings here
Onboarding Expectations:
Learn more about our Onboarding Process here
EEO Statement:
Learn more about our EEO policy here
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Project Manager, Regulatory Affairs (Clinical and CMC)