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Job Description:
Prepare, compile & review Regulatory/Quality documents to support submissions to various markets
Prepare deficiency responses, review labeling information, product monographs and marketing materials under supervision
Prepare post approval supplements / annual reports to support changes and/or manage the regulatory product life cycle as applicable
Seek guidance from other team members and manager as needed, and enhance Regulatory knowledge
Perform additional duties as assigned by the manager
Create and/or revise raw material and packaging specifications using client global specification systems.
Create and manage global change controls for these revisions to the raw material and packaging specifications.
Coordinate and interact with various internal departments like Procurement, Analytical, Technical Assurance and External manufacturers/sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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