US Regulatory Affairs Director
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Job Summary
Providing strategic CMC regulatory leadership, the full-time US Regulatory Affairs Director will manage complex client programs, lead major projects, and drive regulatory strategy while working remotely.
Key responsibilities
- Lead major client projects and act as a senior client-facing advisor to ensure delivery against timelines and quality objectives
- Drive regulatory strategy and health authority interactions using extensive CMC expertise
- Support business growth through proposal development, client relationship management, and mentoring team members
Required qualifications
- Bachelor's degree in business administration, healthcare management, or a related field; Master's degree preferred
- 10+ years of experience in scientific consulting, healthcare, life sciences, or a related field
- 5+ years of experience in a management capacity
- Certification in clinical research or regulatory affairs preferred
- Certification in health economics, outcomes research, or real-world evidence methodologies preferred
Complete Job Description
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