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Job Summary:
- This role leads global regulatory strategies for pipeline programs in immunology and inflammation.
- The incumbent serves as the primary regulatory strategist and Health Authority liaison.
Key Responsibilities:
- Develop integrated regulatory plans and oversee IND/CTA/NDA submissions.
- Lead Health Authority interactions and translate feedback into actionable guidance.
- Ensure regulatory alignment across clinical, CMC, and non-clinical functions.
Qualifications:
- Advanced degree in life sciences with 12+ years of regulatory experience.
- Deep expertise in global regulatory strategy for biologics and small molecules.
- Prior experience in immunology or autoimmune disease is strongly preferred.
Beeline Medicines
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is a small company backed by world-class investors, with a culture of scientific rigor and operational excellence.