Senior Global Regulatory Strategy Lead (Hybrid)

CSL

Opfikon

Hybrid

CHF 197,000 - 220,000

Full time

3 days ago

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Job summary

CSL Behring is seeking a Director, Senior Global Regulatory Lead to shape the global regulatory strategy across product lifecycles. You will partner with Clinical Development, Safety, Commercial, and Research teams, guiding regulatory decisions and ensuring alignment with business objectives.

This is a high-visibility, hybrid role that requires advancing strategies with health authorities worldwide. You will lead and mentor regulatory teams, drive strategic deliverables, and influence senior

Qualifications

Minimum 10 years in biotech/pharma with 8+ years in Regulatory Affairs.
At least 5 years supporting pharmaceutical/biological product development.
5+ years leading teams with strategic direction and talent development.
Strong knowledge of US/EU/Japan regulatory requirements.
Experience working with major health authorities such as FDA/EMA.

Responsibilities

Develop Global Regulatory Strategy for assigned products across lifecycle.
Lead cross-functional regulatory partnership with PSTs and other stakeholders.
Drive health authority engagement with FDA/EMA and regional partners.
Provide regulatory leadership for GRAST and coordinate deliverables.
Influence product development decisions and approve key strategic documents.
Lead strategic regulatory deliverables like Core Briefing Books and Pediatric plans.
Leverage regulatory intelligence and market analytics to inform strategy.
Promote global regulatory alignment across regulatory functions.
Coach and develop regional regulatory leads where applicable.
Demonstrate CSL leadership capabilities and drive accountability.