Senior Director Regulatory Affairs
3 days ago
Meet's Partnership Opportunity
A High-Level Regulatory Affairs Position for a Pediatric Rare Disease Startup
Meet is collaborating with a late-stage pediatric rare disease startup to fill a critical Regulatory Affairs role. This position will report directly to the SVP of Regulatory Affairs and will be responsible for supporting Clinical Regulatory and Regulatory CMC functions. The company has recently announced positive P3 data for its lead drug candidate and is in the process of filing an NDA.
Key Responsibilities:
- Develop and execute regulatory strategies to support major submissions
- Lead cross-functional teams to ensure accurate and timely regulatory documentation
Requirements and Qualifications:
- At least 12 years of experience in Regulatory Affairs, with a mix of Clinical Reg and Reg CMC experience preferred
- NDA/late-stage experience is highly desirable
- Non-oncology experience is required, with a preference for rare disease experience
- Small molecule development experience is required
- Startup experience is highly preferred
About Meet
Meet is a company that partners with innovative startups to fill critical roles. We are committed to helping our clients succeed in their respective industries.
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