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Sr Specialist, Regulatory Affairs

Company

West Pharmaceutical Services

Location

Exton, Pennsylvania

Posted

July 02, 2026

Position Overview

Job Summary

The Sr. Specialist, Regulatory Affairs is responsible for the publishing, formatting, and maintenance of regulatory documentation supporting West’s global product portfolios. This role ensures regulatory submissions are prepared accurately and in compliance with applicable global health authority requirements. This position operates independently on assigned regulatory projects, collaborates cross-functionally, and escalates regulatory risks appropriately to Regulatory Affairs leadership. The role focuses on high-quality execution, compliance, and continuous improvement within established regulatory frameworks.

Essential Duties and Responsibilities

  • Publish, format, and maintain regulatory submissions (DMFs, Dossiers, MAFs, 510(k)s, and related filings) in alignment with global regulatory requirements

  • Compile and prepare electronic submission packages according to regional health authority guidelines and i...
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