Job Description

Regulatory Affairs Specialist
A Regulatory Affairs Specialist is responsible for supporting regulatory compliance activities, preparing and coordinating regulatory submissions, and ensuring products and processes meet applicable regulatory requirements. The role involves working across multiple functions to support approvals, registrations, audits, and regulatory strategy while contributing to project delivery and continuous improvement initiatives.
Responsibilities
Prepare and coordinate document packages for regulatory submissions, audits, inspections, license renewals, and annual registrations.
Compile and review all materials required for regulatory submissions and ongoing compliance activities.
Support and recommend changes to labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance.
Monitor, maintain, and improve regulatory tracking and control systems.
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