Director, CMC Regulatory Affairs

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• Develop and implement global CMC regulatory strategies for biologic and combination products. • Prepare and manage CMC submissions, briefing documents, and health authority meeting packages, including INDs, CTAs, BLAs, MAAs, and post-approval filings, 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, guidance documents, and changes to global regulatory requirements affecting CMC. • Support product release, investigations, inspections, and relevant SOP reviews.

🎯 Requirements

• Bachelor’s degree in a scientific discipline, such as Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field. • Minimum of 10 years of experience in Regulatory Affairs, CMC, or related pharmaceutical or biotechnology functions, with significant biologics experience. • Proven experience developing and executing global CMC regulatory strategies for biologics across clinical and commercial stages. • Strong knowledge of global CMC regulatory requirements and experience with INDs, IMPDs, CTAs, BLAs, MAAs, and post-approval submissions. • Solid understanding of biologics and combination product development and manufacturing, including analytical methods, process validation, comparability, specifications, and stability. • Experience supporting health authority interactions, including regulatory meetings and responses to agency questions. • Ability to assess regulatory impacts of product, process, manufacturing, and lifecycle changes and develop appropriate regulatory strategies. • Strong leadership, project management, communication, and cross-functional collaboration skills. • Experience with biologics and combination products, including prefilled syringes and autoinjectors, is preferred.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development