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Role Overview:
- We are seeking a dynamic CMC Regulatory Affairs leader to join our Regulatory team.
- This position provides strategic and operational leadership for global CMC regulatory activities.
Key Responsibilities:
- Develop and implement global CMC regulatory strategies for biologic and combination products.
- Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Qualifications:
- Bachelor's degree in a scientific discipline with at least 10 years of regulatory affairs experience.
- Proven experience in global CMC regulatory strategies for biologics across clinical and commercial stages.
Jade Biosciences
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.