Global Regulatory CMC Lead — Biologics & Non-Biol

CSL; Bern; Hybrid; CHF 180,000 - 240,000; Full time

Job summary

CSL is seeking a Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products to lead global regulatory CMC strategy, partnering with R&D, Manufacturing, Quality and Regulatory Affairs to address strategy challenges and deliver compliant, timely regulatory solutions across the portfolio.

You will oversee submissions, change controls, and interactions with health authorities, ensuring alignment with evolving international standards while guiding cross-functional teams to achieve

Qualifications

• Bachelor’s degree in biological or chemical sciences required; MS/PhD preferred.
• Over 5 years of progressive regulatory experience in biologics or plasma.
• Strong knowledge of global regulatory requirements for drug product development and lifecycle.
• Proven ability to lead cross-functional teams and collaborate with key stakeholders.
• Experience authoring and managing regulatory submissions with timelines.

Responsibilities

• Lead global regulatory CMC strategy across the product portfolio.
• Manage development and submission of regulatory submissions and components.
• Oversee change control assessments in CSL’s quality system for biological & non-biol. products.
• Represent CSL in official regulatory CMC capacities with agencies.
• Develop strategic plans for Global Regulatory Affairs CMC and advise leadership.
• Provide regulatory input to internal CSL functions to ensure compliance and efficiency.

Skills

Regulatory strategy

CMC expertise

Cross-functional leadership

Authoring submissions

Regulatory communications

Change control

Project management

Stakeholder management

Negotiation

Written communication

Education

Bachelor's degree in biological or chemical sciences

MS or PhD preferred

Job description

CSL is seeking a Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products to lead global regulatory CMC strategy, partnering with R&D, Manufacturing, Quality and Regulatory Affairs to address strategy challenges and deliver compliant, timely regulatory solutions across the portfolio.

You will oversee submissions, change controls, and interactions with health authorities, ensuring alignment with evolving international standards while guiding cross-functional teams to achieve