Global Regulatory Affairs CMC Lead – Biologics & Non-Bio

CSL; Bern; Híbrido; CHF 140.000 - 190.000; Jornada completa

Descripción de la vacante

CSL is seeking a Senior Manager Global Regulatory Affairs CMC for Biological & Non-Biol. Products to lead global CMC regulatory strategies. You will partner with R&D, Manufacturing, Quality and Regulatory Affairs to address strategy challenges and deliver timely regulatory solutions that meet evolving CMC requirements.

You will manage submissions, change controls, and provide regulatory consultation across CSL functions to support lifecycle management and business objectives.

Formación

• Bachelor’s degree in biological or chemical sciences required; advanced degree preferred.
• 5+ years in regulatory roles in biologics/plasma.
• Strong knowledge of global regulations and standards for drug development and lifecycle.

Responsabilidades

• Lead global regulatory CMC strategy across assigned portfolio with cross-functional leaders.
• Manage development and submission of high-quality regulatory submissions and components.
• Ensure timely change control assessments in CSL quality systems for product-related changes.
• Leverage external insights to refine regulatory strategies and approaches.
• Represent CSL in official regulatory capacities and maintain regulator relationships.
• Provide regulatory consultation to internal CSL functions to ensure compliance and efficiency.

Conocimientos

CMC Regulatory Strategy

Cross-functional Leadership

Regulatory Submissions

Authoring & Reviewing

Stakeholder Management

Educación

Bachelor's degree in Biological/Chemical Sciences

Advanced degree preferred

Descripción del empleo

CSL is seeking a Senior Manager Global Regulatory Affairs CMC for Biological & Non-Biol. Products to lead global CMC regulatory strategies. You will partner with R&D, Manufacturing, Quality and Regulatory Affairs to address strategy challenges and deliver timely regulatory solutions that meet evolving CMC requirements.

You will manage submissions, change controls, and provide regulatory consultation across CSL functions to support lifecycle management and business objectives.