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