Director, Regulatory Strategist
$112,000–$236,000 year
Hybrid · Washington, District of Columbia, United States
Job Summary
Director, Regulatory Strategist role focused on developing and implementing global/regional regulatory strategies for complex products, including novel and post-approval projects. Responsible for preparing regulatory submissions (IND, NDA, MAA), providing regulatory input to clinical development programs, contributing to labeling and CCDS activities, coordinating with Health Authorities, organizing meetings, leading regulatory due diligence, and partnering with cross-functional teams to ensure timely, high-quality regulatory deliverables. Hybrid role requiring DC office presence 2 days/week; travel as needed. Proficiency in English required; extensive US/EU regulatory know-how and track record of successful interactions with Health Authorities are expected.
Required Qualifications
- B.S. Scientific Degree required
- Minimum 8 years US, EU, EM Regulatory experience required
- Minimum 5 years Global Regulatory experience preferred
- Regulatory submissions experience (IND, NDA, MAA)
- Proven ability to manage global/regional regulatory and registration activities
- Regulatory Affairs Professional Certification preferred
- Strong written and verbal communication skills
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