Manager, Regional Regulatory Lead

CSL; Waltham (MA); On-site; USD 130,000 - 180,000; Full time

Job summary

CSL in the United States is seeking a Manager, Regional Regulatory Lead to drive regulatory strategy for biotherapies, vaccines, and plasma-derived therapies across assigned regions.

You will lead planning, preparation, and submission of regulatory dossiers, ensure compliance with global and regional requirements, and support inspections and audits in a patient-focused, science-driven, and collaborative environment.

Responsibilities

• Lead regulatory strategy across assigned regions.
• Plan, prepare, and submit regulatory dossiers.
• Ensure compliance with global and regional requirements.
• Serve as liaison with health authorities.
• Provide strategic regulatory guidance to cross-functional teams.
• Monitor evolving regulations and support inspections and audits.

Job description

CSL is seeking a Manager, Regional Regulatory Lead to drive regulatory strategy for our biotherapies, vaccines, and plasma-derived therapies across assigned regions. In this role, you will lead the planning, preparation, and submission of regulatory dossiers, ensure compliance with global and regional requirements, and serve as a key liaison with health authorities. You will provide strategic regulatory guidance to cross-functional teams, monitor evolving regulations, and support inspections and audits. This position offers the opportunity to contribute directly to life‑saving therapies in a patient‑focused, science‑driven, and collaborative environment.