GRA CMC Specialist

Role: Lead global regulatory CMC strategy development for biologics and plasma-derived therapies, focusing on enterprise-wide compliance projects and digital innovation integration. Responsibilities: shape regulatory strategies, oversee compliance for CAPEX projects, manage relationships with outsourcing vendors, monitor evolving global regulations (FDA, EMA, PMDA, NMPA), and coordinate key CMC activities such as change control, inspections, and due diligence. Drive digital transformation using AI/ML solutions, define KPIs to measure operational impact, and support policy development aligned with international standards. Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, and External Affairs to ensure regulatory readiness and strategic alignment.Qualifications: Bachelor’s degree in biological/chemical sciences required; MS or PhD preferred. Over 5 years’ progressive regulatory experience in biologics or plasma industry, with deep knowledge of global regulations, submissions management, and lifecycle planning. Skills: strong stakeholder management, vendor oversight, regulatory intelligence interpretation, excellent communication, and leadership within matrix organizations. HighValue: biologics, plasma-derived therapies, global CMC regulation, digital innovation in regulatory processes, compliance, and lifecycle management. WorkSetup: not specified; likely hybrid/remote with global stakeholder collaboration.