Manager, Regulatory Compliance
Core
Manage site regulatory compliance processes, reporting, licensing, and documentation (Site Master File, Quality Manual) for a pharmaceutical manufacturing facility.
Role type
Manager, Regulatory Compliance
Builds
Regulatory compliance programs and documentation supporting site operations and inspections.
Domain
Pharmaceutical manufacturing / API manufacturing
Required skills
Pharmaceutical regulations, GMP, regulatory submissions, licensing, inspection support, CAPAs, change controls, risk management, team leadership
Preferred skills
Site Master File management, Quality Technical Agreements
Technologies
None stated
Responsibilities
Lead and maintain site regulatory compliance programs; manage regulatory submissions and licensing; maintain Site Master File and Quality Manual; negotiate Quality Technical Agreements; support regulatory agency inspections; coordinate corrective action plans; partner with cross-functional teams on investigations and risk assessments; lead and develop Regulatory Compliance personnel.
Seniority
Manager, people management