Global Regulatory CMC Lead – Biologics & Non-Bio

CSL; Schweiz; On-site; CHF 160,000 - 210,000; Full time

Job summary

CSL is seeking a Regulatory Affairs leader to define global CMC strategies for biological and non-biol products, partnering with R&D, Manufacturing, Quality, and Regulatory Affairs to ensure compliant lifecycle management.

You will author and review regulatory submissions, manage change controls, and maintain strong regulator relationships to support timely approvals and market access across regions.

Qualifications

• Bachelor's degree in biological or chemical sciences or related field is required.
• Advanced degree (MS/PhD) strongly preferred.
• 5+ years of progressive regulatory experience in biologics/plasma.

Responsibilities

• Lead global regulatory CMC strategy across development and commercial portfolios.
• Manage development and submission of regulatory submissions and components.
• Ensure timely change control assessments within CSL's quality system.
• Leverage external insights to refine regulatory strategies and approaches.
• Represent CSL in official regulatory CMC interactions and maintain regulator relationships.
• Develop strategic plans for Global Regulatory Affairs CMC and advise leadership.
• Provide regulatory consultation across Global Operations, R&D, IT and other functions.
• Contribute to contingency planning and issue resolution while complying with regulations.

Skills

Regulatory strategy

CMC knowledge

Regulatory submissions

Change control

Cross-functional leadership

Stakeholder management

Education

Bachelor's degree in biological or chemical sciences

Advanced degree (MS, PhD) preferred

Job description

CSL is seeking a Regulatory Affairs leader to define global CMC strategies for biological and non-biol products, partnering with R&D, Manufacturing, Quality, and Regulatory Affairs to ensure compliant lifecycle management.

You will author and review regulatory submissions, manage change controls, and maintain strong regulator relationships to support timely approvals and market access across regions.