Global Regulatory CMC Strategy Lead (Biologics)

CSL; Bern; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Benefits dieser Stelle

Health benefits

Zusammenfassung

CSL is seeking a senior regulatory affairs professional to develop global CMC strategies and drive enterprise-wide compliance initiatives. You will collaborate with Global Regulatory Affairs, R&D, Quality, and IT to implement digital solutions that enhance regulatory operations.

The role requires directing outsourcing partners, monitoring regulatory changes, and guiding senior leadership on requirements and timelines.

Qualifikationen

• Bachelor’s degree in biological or chemical sciences required.
• Advanced degree (MS/PhD) preferred.
• 5+ years in regulatory roles within biologics or plasma.
• Strong knowledge of global drug regulations and standards.
• Experience authoring and managing regulatory submissions.

Aufgaben

• Develop global regulatory CMC strategies for enterprise-wide projects.
• Assess and implement digital innovations for regulatory CMC activities.
• Manage outsourcing vendors and coordination across geographies.
• Monitor evolving global CMC regulations and communicate implications.
• Support policy initiatives and strategic regulatory planning.
• Lead cross-functional teams and mentor staff.

Kenntnisse

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Regulatory intelligence

Ausbildung

Bachelor’s degree in biological or chemical sciences

Advanced degree (MS/PhD) preferred

Jobbeschreibung

CSL is seeking a senior regulatory affairs professional to develop global CMC strategies and drive enterprise-wide compliance initiatives. You will collaborate with Global Regulatory Affairs, R&D, Quality, and IT to implement digital solutions that enhance regulatory operations.

The role requires directing outsourcing partners, monitoring regulatory changes, and guiding senior leadership on requirements and timelines.