Jade Biosciences - Director, CMC Regulatory Affairs

Remote - USA$210k - $235k1mo ago

Remote Director NA Pharmaceuticals Biotechnology Regulatory Affairs Manager Regulatory Affairs Documentation Partnership Development Cross-functional Collaboration

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.

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, 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.