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BioSpace

Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (S

BioSpace, Boston

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Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)

Join to apply for the Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) role at BioSpace

This position is currently active and accepting applications.

About the role: The Plasma-Derived Therapies (PDT) R&D Organization focuses on developing plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence oversees global regulatory affairs operations for the PDT BU portfolio.

Responsibilities include:

  • Supporting global regulatory submissions and ensuring timely execution.
  • Providing strategic leadership on regulatory compliance and process efficiencies.
  • Managing relationships with external vendors and internal teams.
  • Participating in leadership decisions and strategic planning.

Qualifications: Bachelor's degree or related experience, 7-10 years in regulatory affairs, management experience, and knowledge of global drug development regulations.

Additional details include compensation, benefits, company culture, and application instructions.

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