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Manager, Regulatory Compliance at Catalent - ApplyBlast

Manager, Regulatory Compliance

Catalent

19 hours ago

2.9 on Glassdoor

Kansas City, Missouri, United States

Onsite

Full Time

Manager

0 applicants

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About this role

The Manager, Regulatory Compliance oversees site regulatory compliance processes, including reporting, licensing support, and documentation like the Site Master File and Quality Manual. This role collaborates with various teams to support inspections, fulfill commitments, and drive continuous improvement while leading and developing Regulatory Compliance personnel. The position ensures adherence to regulatory requirements and current Good Manufacturing Practices.

Responsibilities

Lead and maintain site regulatory compliance programs to ensure adherence to applicable requirements
Manage regulatory submissions, commercial data reporting, licensing activities, and maintenance of regulatory records
Support regulatory agency, customer, and pre-approval inspections through documentation preparation and coordination