Global Regulatory CMC Strategist

BioSpace; Waltham (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

CSL Behring in the United States seeks a senior regulatory affairs professional to develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects, collaborating with Global Regulatory Affairs CMC, R&D, Quality, and other functions.

You will lead digital innovation, oversee outsourcing vendors, monitor global regulations (FDA, EMA, PMDA, NMPA), coordinate change control, due diligence, and regulatory submissions, and advise senior leadership on timelines and risk.

Qualifications

• Bachelor's degree in biological or chemical sciences required; MS/PhD preferred.
• Over 5 years of progressive regulatory experience in biologics or plasma.
• Deep knowledge of global regulations governing drug development and lifecycle.

Responsibilities

• Develop global regulatory CMC strategies for enterprise-wide projects with cross-functional teams.
• Advise on regulatory intelligence and ensure alignment with strategic plans.
• Manage outsourcing vendors and coordinate deliverables, timelines, and compliance.
• Monitor regulatory developments (FDA, EMA, PMDA, NMPA) and communicate implications to stakeholders.
• Lead change control, due diligence, and template management for CTD sections; support inspections.

Skills

Regulatory affairs

CMC

Global regulations

Vendor management

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in biological/chemical sciences

MS/PhD preferred

Job description

CSL Behring in the United States seeks a senior regulatory affairs professional to develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects, collaborating with Global Regulatory Affairs CMC, R&D, Quality, and other functions.

You will lead digital innovation, oversee outsourcing vendors, monitor global regulations (FDA, EMA, PMDA, NMPA), coordinate change control, due diligence, and regulatory submissions, and advise senior leadership on timelines and risk.