Global Regulatory CMC Strategist – Biologics/Plasma

CSL Behring; False Pass (AK); On-site; USD 150,000 - 190,000; Full time

Job summary

CSL Behring seeks an experienced Regulatory CMC professional to align global strategies for biologics and plasma-derived therapies. You will partner with Global Regulatory Affairs, Global Operations, and R&D to deliver compliant, timely CMC submissions and lifecycle management.

The role emphasizes digital optimization, vendor management, and policy shaping to support CSL's strategic objectives while ensuring alignment with international standards and regulatory requirements.

Qualifications

• Bachelor's degree in biological or chemical sciences required.
• 5+ years in regulatory roles within biologics or plasma industries.
• Strong knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and lifecycle management.
• Experience authoring and managing regulatory submissions at federal and state levels.
• Proven ability to lead cross-functional teams and collaborate with key stakeholders.

Responsibilities

• Develop global regulatory CMC strategies for enterprise initiatives in collaboration with Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, and Global Operations.
• Assess and facilitate digital innovation for Global Regulatory Affairs CMC, including AI/ML applications for regulatory submission and regulatory intelligence.
• Manage relationships with outsourcing vendors and external partners, coordinating deliverables and timelines across geographies.
• Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA, etc.).
• Coordinate key regulatory CMC activities including change control, due diligence, template management for CTD sections, deviation support, and inspection support.
• Support collaboration with Corporate & External Affairs to shape policy and regulatory frameworks affecting lifecycle management of plasma-derived therapies.
• Contribute to strategic and tactical plans for Global Regulatory Affairs CMC and advise senior leadership on regulatory implications for timelines and business strategy.

Skills

Regulatory strategy

Cross-functional leadership

Global regulatory affairs

Regulatory submissions

Education

Bachelor's degree in biological or chemical sciences

MS/PhD preferred

Job description

CSL Behring seeks an experienced Regulatory CMC professional to align global strategies for biologics and plasma-derived therapies. You will partner with Global Regulatory Affairs, Global Operations, and R&D to deliver compliant, timely CMC submissions and lifecycle management.

The role emphasizes digital optimization, vendor management, and policy shaping to support CSL's strategic objectives while ensuring alignment with international standards and regulatory requirements.