GRA CMC Specialist

The GRA CMC Specialist works within CSL, a developer of plasma‑derived therapies, and collaborates closely with global regulatory affairs and operations teams to shape regulatory chemistry, manufacturing and controls (CMC) approaches that satisfy shifting compliance demands. Each day the role crafts worldwide CMC strategies for capital‑intensive and compliance initiatives, partners with functional leaders across regulatory, research, quality and operations, and evaluates digital tools—including artificial‑intelligence and machine‑learning solutions—that support submission and intelligence workflows. The specialist also oversees relationships with external vendors, tracks performance metrics, interprets updates from agencies such as the FDA, EMA, PMDA and NMPA, and disseminates this intelligence internally. Additional duties involve coordinating change‑control activities, due‑diligence for potential deals, template upkeep for quality sections, and providing support for inspections and legislative engagements that influence policy for plasma products. Candidates must hold a bachelor’s degree in a biological or chemical discipline, with a master’s or doctorate viewed favorably, and bring more than five years of progressive regulatory experience in the biologics or plasma field. A solid grasp of international drug‑product regulations, proven ability to author and review submissions at federal and state levels, and a record of leading cross‑functional teams are essential. Strong written and verbal communication, negotiation talent, and a commitment to high‑integrity compliance are also required. Desirable expertise includes familiarity with AI/ML applications for regulatory processes, experience defining key performance indicators for digital initiatives, and a history of managing outsourced activities across multiple regions. The position operates in a matrixed, globally dispersed environment that values accountability, results‑orientation and the capacity to translate regulatory strategy into business advantage.