Director of Regulatory Affairs
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Job Summary
As a strategic regulatory lead, the full-time Director of Regulatory Affairs will develop and implement global regulatory strategies for oncology programs, ensuring compliance and driving regulatory submissions while working remotely.
Key Responsibilities
- Develop and implement innovative regulatory strategies for assigned oncology programs from first-in-human through post-marketing stages
- Lead the preparation and submission of INDs, NDAs, and other regulatory filings, ensuring high quality and compliance
- Collaborate with cross-functional teams to integrate regulatory strategies across all development activities
Required Qualifications
- B.S. or M.S. in a scientific discipline with a minimum of 12 years of experience in pharmaceutical Regulatory Affairs
- Advanced knowledge and experience with oncology drug development regulations in the US and EU
- Proven track record in preparing and submitting INDs, NDAs, and other major regulatory filings
- Experience engaging with FDA and other global regulatory agencies
- Demonstrated ability to lead and manage multiple complex projects simultaneously
Complete Job Description
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