Global Regulatory CMC Lead – Biologics & Non-Biologics

CSL; Waltham (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

CSL is seeking a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will collaborate with R&D, Manufacturing, Quality, and Regulatory Affairs to deliver compliant, timely regulatory solutions.

You will lead submissions, manage change controls, and interact with regulators as an authorized official, shaping lifecycle management and strategic opportunities at CSL.

Qualifications

• Bachelor's degree in biological or chemical sciences is required; an advanced degree is strongly preferred.
• Over 5 years of progressive regulatory experience in biologics or plasma.
• Strong knowledge of global regulations governing drug development, manufacture, registrations, and lifecycle management.
• Expertise in authoring and managing regulatory submissions with timely delivery.
• Ability to lead cross-functional teams and collaborate effectively with stakeholders.

Responsibilities

• Lead global regulatory CMC strategy across biological and non-biol product portfolio.
• Manage development and submission of high-quality regulatory submissions and components.
• Ensure timely change control assessments within CSL's quality management system.
• Represent CSL in regulatory CMC capacities with authorities; maintain regulator relationships.
• Develop strategic plans and advise leadership on regulatory requirements and impact.

Skills

Regulatory strategy

CMC regulatory affairs

Cross-functional leadership

Regulatory submissions

Communication

Project management

Education

Bachelor’s degree in biological or chemical sciences

Advanced degree preferred (MS/PhD)

Job description

CSL is seeking a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will collaborate with R&D, Manufacturing, Quality, and Regulatory Affairs to deliver compliant, timely regulatory solutions.

You will lead submissions, manage change controls, and interact with regulators as an authorized official, shaping lifecycle management and strategic opportunities at CSL.