Associate, ESOQ Regulatory Operations
Core
Support post-approval changes, initial registrations, renewals, and regulatory compliance assessments for pharmaceutical products.
Role type
Associate Regulatory Operations Specialist
Builds
Regulatory dossiers and change management records for drug and medical devices
Domain
Pharmaceutical / Regulatory Affairs
Required skills
GXP compliance, Change Management, US/EU/global cGMP knowledge, regulatory strategy, dossier compliance assessment, complaint management, SAP material master workflow
Preferred skills
QA/QC principles, supplier quality management, cross-functional collaboration, AI tool usage
Technologies
GMP systems, SAP
Responsibilities
Support Post Approval Changes, initial registrations and/or renewals; Perform preliminary regulatory impact assessment; Coordinate collection of supporting documents; Act as liaison between CMOs and internal functions; Support investigations into regulatory discrepancies; Manage complaints for commercial Drug Product and Medical Device; Review and approve SAP material master workflow tasks
