Job Description

Senior Regulatory Affairs Specialist

A Regulatory Affairs Specialist is responsible for supporting and leading regulatory submission activities, ensuring compliance with applicable regulations, and coordinating cross-functional efforts to achieve timely approvals. The role involves managing regulatory documentation, supporting audits and inspections, and driving continuous improvement of regulatory processes.

Responsibilities

  • Coordinate and prepare regulatory submission packages, including applications, renewals, registrations, and supporting documentation.
  • Compile, review, and manage materials required for regulatory submissions and ongoing compliance activities.
  • Support and lead interactions related to regulatory audits, inspections, and agency requests.
  • Review and recommend updates to labeling, manufacturing processes, marketing materials, and clinical documentation to maintain regulatory compliance.
  • Monitor regulat...

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