Senior Global Regulatory CMC Lead

CSL Behring; Bern; On-site; CHF 180,000 - 260,000; Full time

Job summary

CSL Behring seeks a Senior Manager Global Regulatory Affairs CMC for Biological and Non-Biological products to define and implement global regulatory strategies across product portfolios. You will lead submissions, ensure compliance, and advise cross‑functional teams to align with evolving regulatory expectations.

The role requires strong leadership, deep CMC knowledge, and effective interaction with regulatory authorities to drive timely approvals and lifecycle management.

Qualifications

• Bachelor’s degree in biological or chemical sciences; advanced degree (MS, PhD) preferred.
• Over 5 years of progressive regulatory experience in biologics or plasma.
• Strong knowledge of global regulations governing drug product development and lifecycle management.
• Proven expertise in authoring and managing regulatory submissions.
• Ability to lead cross-functional teams and collaborate with stakeholders.

Responsibilities

• Lead global regulatory CMC strategy across biological and non-biological product portfolio.
• Manage development and submission of high-quality regulatory submissions and components.
• Ensure change control assessments are accurate and timely in quality systems.
• Leverage external insights to refine regulatory strategies and improve positioning.
• Represent CSL in official regulatory CMC capacities with authorities.
• Develop strategic plans for Global Regulatory Affairs CMC and advise leadership.
• Provide regulatory consultation to internal CSL functions to ensure compliance.

Job description

CSL Behring seeks a Senior Manager Global Regulatory Affairs CMC for Biological and Non-Biological products to define and implement global regulatory strategies across product portfolios. You will lead submissions, ensure compliance, and advise cross‑functional teams to align with evolving regulatory expectations.

The role requires strong leadership, deep CMC knowledge, and effective interaction with regulatory authorities to drive timely approvals and lifecycle management.