Global Regulatory CMC Strategist

CSL; Waltham (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

CSL in Massachusetts seeks an experienced Regulatory Affairs leader to shape global regulatory CMC strategy for plasma-derived therapies. You will collaborate with R&D, Quality, Global Operations, and external partners to drive compliant, timely submissions across geographies.

The role emphasizes digital innovation, KPI-driven performance, and change control activities, with oversight of outsourcing, vendor relationships, and regulatory intelligence for FDA, EMA, PMDA, and global agencies.

Qualifications

• Bachelor’s degree in biological or chemical sciences or related field; advanced degree preferred.
• 5+ years of progressive regulatory experience in biologics/regulatory CMC.
• Strong knowledge of global regulations and standards governing drug product development and lifecycle management.
• Experience authoring and managing regulatory submissions at federal and state levels.

Responsibilities

• Develop global regulatory CMC strategies for enterprise programs across multiple functions.
• Assess and implement digital innovations to support regulatory operations and submissions.
• Manage outsourcing/vendor relationships; coordinate timelines and compliance.
• Monitor and interpret evolving global regulatory requirements (FDA/EMA/PMDA/NMPA).
• Coordinate key CMC activities: change control, due diligence, CTD templates, deviations, inspections.
• Collaborate with Corporate & External Affairs on regulatory policy initiatives.
• Advise senior leadership on regulatory requirements and project timelines.

Skills

Regulatory strategy

Global Regulatory Affairs

Cross-functional leadership

Regulatory submissions

Communication

Digital innovation

Vendor management

Education

Bachelor's degree in biological or chemical sciences

MS or PhD preferred

Tools

FDA/EMA/PMDA knowledge

Job description

CSL in Massachusetts seeks an experienced Regulatory Affairs leader to shape global regulatory CMC strategy for plasma-derived therapies. You will collaborate with R&D, Quality, Global Operations, and external partners to drive compliant, timely submissions across geographies.

The role emphasizes digital innovation, KPI-driven performance, and change control activities, with oversight of outsourcing, vendor relationships, and regulatory intelligence for FDA, EMA, PMDA, and global agencies.