Regulatory Affairs Consultant – Compliance & Process (hybrid)

Parexel

📍 Włochy, Mazowieckie, Poland

Full time Business Operations Specialists

Job Description

When our values align, there's no limit to what we can achieve.
 

We are seeking a highly collaborativeRegulatory Affairs Consultant – Compliance & Processto strengthen global regulatory compliance and quality operations across GxP environments. You will partner with Regulatory Affairs, Quality, CMC, Clinical Operations, and other cross-functional teams to enable compliant, efficient, and scalable business operations.

This is a client dedicated project and the role requires to be in the Warsaw office (hybrid model).

Key Responsibilities

Controlled Document Management & Governance

  • Serve as SME for controlled document management, ensuring compliant governance and inspection readiness

  • Author, review, approve, and manage controlled procedures and quality documents per GxP requirements

  • Drive document lifecycle management activities including creation, revision, periodic review, and archiv...

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