Director of Regulatory Affairs
Company: VirtualVocations
Location: Humble
Posted on: March 23, 2025
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Job Description:
A company is looking for a Director, Regulatory Submission
Lead.
Key Responsibilities
Oversee the planning, management, and execution of regulatory
submissions, including major submissions like (s)NDA and MAA
Ensure high-quality dossiers meet regulatory standards and
communicate key submission requirements with Global Regulatory
Leads
Drive continuous improvement in submission processes and maintain
submission-related SOPs and Work Instructions
Required Qualifications
Bachelor's degree in a life science concentration; a postgraduate
degree in Regulatory Affairs is preferred
10+ years of experience in Regulatory Affairs, including oncology
experience
Extensive experience in major regulatory submissions and project
management
Deep understanding of relevant regulatory guidance documents
Proficiency in software relevant for regulatory project management
and submission preparation
Keywords: VirtualVocations, Houston , Director of Regulatory Affairs, Executive , Humble, Texas
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