Global Regulatory CMC Leader for Biologics & Non-Biologics

CSL; Bern; Híbrido; CHF 180 000 - 240 000; Tempo integral

Resumo da oferta

CSL is seeking a Senior Manager Global Regulatory Affairs CMC to lead global regulatory strategies for biological and non-biological products. You will collaborate with R&D, Manufacturing, Quality, and Regulatory Affairs to deliver compliant CMC submissions, assess change controls, and influence regulatory policy while guiding external interactions with authorities.

You will shape global CMC plans, provide regulatory insights to internal teams, and ensure alignment with CSL's strategic

Qualificações

• Bachelor-level degree in biological or chemical sciences required; advanced degree preferred.
• 5+ years in regulatory roles within biologics/plasma with increasing responsibilities.
• Strong knowledge of global regulatory standards governing drug development, manufacture, registration and life-cycle management.

Responsabilidades

• Lead global Regulatory CMC strategy across the product portfolio with cross-functional leaders.
• Manage development and submission of high-quality regulatory submissions and components.
• Ensure change control assessments in CSL's quality system for product-related changes.
• Provide regulatory consultation to internal CSL functions to support compliance and efficiency.
• Represent CSL in regulatory CMC interactions with authorities and maintain regulator relationships.
• Develop strategic/tactical plans for Global Regulatory Affairs CMC and support business timing.

Conhecimentos

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Quality systems

Regulatory affairs

Regulator liaison

Project management

Formação académica

BSc in biological/chemical sciences

MS/PhD preferred

Descrição da oferta de emprego

CSL is seeking a Senior Manager Global Regulatory Affairs CMC to lead global regulatory strategies for biological and non-biological products. You will collaborate with R&D, Manufacturing, Quality, and Regulatory Affairs to deliver compliant CMC submissions, assess change controls, and influence regulatory policy while guiding external interactions with authorities.

You will shape global CMC plans, provide regulatory insights to internal teams, and ensure alignment with CSL's strategic