Director, CMC Regulatory Affairs

About the Company

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy.

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 (INDs, CTAs, BLAs, MAAs, etc.)
• Serve as the CMC Regulatory lead on cross-functional project teams
• Support health authority interactions and responses to regulatory questions
• Provide regulatory guidance on manufacturing, analytical, quality, and lifecycle topics
• Assess regulatory impact of manufacturing and lifecycle changes and develop risk mitigation strategies
• Collaborate with internal teams and external partners to support development and commercialization
• Stay abreast of regulatory trends and changes to global CMC requirements
• Support product release, investigations, inspections, and relevant SOP reviews

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field
• Minimum of 10 years of experience in Regulatory Affairs, CMC, or related biotechnology functions
• Significant experience with biologics
• Proven experience executing global CMC regulatory strategies across clinical and commercial stages
• Strong knowledge of global CMC regulatory requirements (INDs, IMPDs, CTAs, BLAs, MAAs)
• Solid understanding of biologics and combination product development and manufacturing
• Experience supporting health authority interactions and regulatory meetings
• Strong leadership, project management, and cross-functional collaboration skills

Preferred Qualifications

• Experience with biologics and combination products, including prefilled syringes and autoinjectors